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The concepts of Safe by Design (SbD) and Safe and Sustainable by Design (SSbD) are receiving increasing attention. The definitions of both concepts include the term ‘life cycle’ in combination with the terms ‘chemical’, ‘material’ and ‘product’, but their meanings are not further elaborated and defined in scholarly publications on SbD/SSbD. Here, we address two research questions: (1) How are the terms chemical, material and product used and defined in the scholarly literature on SbD and SSbD; (2) How are life cycles defined and which are considered in the scholarly literature on SbD/SSbD? We found largely consistent, though still confusing, uses of the terms product, material and chemical and we found four types of life cycles in the reviewed papers. Using consistent definitions of the terms product, material and chemical, we reduce the four types of life cycles found to three types of distinctive life cycles: (1) the life cycle of a product; (2) the life cycle of a chemical in a specific product; (3) the life cycle of a chemical in all its product applications. We discuss the different trade-offs that each of these life cycle approaches canidentify and argue that they are complementary and should preferably all be applied in SbD/SSbD studies.

The Safe by Design (SbD) concept aims to ensure the production, use and disposal of materials and products safely. While there is a growing interest in the potential of SbD to support policy commitments, such as the EU Green Deal and the Circular Economy Action Plan in Europe, methodological approaches and practical guidelines on SbD are, however, largely missing. The combined use of Life Cycle Assessment (LCA) and Risk Assessment (RA) is considered suitable to operationalize SbD over the whole life-cycle of a product. Here, we explore the potential of the combined use of LCA and RA at Technological Readiness Level (TRL) 1–6. We perform a review of the literature presenting and/or developing approaches that combine LCA and RA at early stages of product design. We identify that basic early-on-evaluations of safety (e.g., apply lifecycle thinking to assess risk hotspots, avoid use of hazardous chemicals, minimize other environmental impacts from chemicals) are more common, while more complex assessments (e.g., ex-ante LCA, control banding, predictive (eco)toxicology) require specialized expertise. The application of these simplified approaches and guidelines aims to avoid some obvious sources of risks and impacts at early stages. Critical gaps need to be addressed for wider application of SbD, including more studies in the product design context, developing tools and databases containing collated information on risk, greater collaboration between RA/LCA researchers and companies, and policy discussion on the expansion from SbD to Safe and Sustainable by Design (SSbD).

The concepts of Safe by Design (SbD) and Safe and Sustainable by Design (SSbD) are receiving increasing attention. The definitions of both concepts include the term ‘life cycle’ in combination with the terms ‘chemical’, ‘material’ and ‘product’, but their meanings are not further elaborated and defined in scholarly publications on SbD/SSbD. Here, we address two research questions: (1) How are the terms chemical, material and product used and defined in the scholarly literature on SbD and SSbD; (2) How are life cycles defined and which are considered in the scholarly literature on SbD/SSbD? We found largely consistent, though still confusing, uses of the terms product, material and chemical and we found four types of life cycles in the reviewed papers. Using consistent definitions of the terms product, material and chemical, we reduce the four types of life cycles found to three types of distinctive life cycles: (1) the life cycle of a product; (2) the life cycle of a chemical in a specific product; (3) the life cycle of a chemical in all its product applications. We discuss the different trade-offs that each of these life cycle approaches canidentify and argue that they are complementary and should preferably all be applied in SbD/SSbD studies.

Personal care products (PCPs) are highly used in daily routines since they comprise the formulations of facewashes, makeup cosmetics, shampoos, conditioners, beauty products, among others. The wastewater treatment plant (WWTP) effluents are considered as major sources of PCPs in the aquatic environment, since many of these compounds are resistant to the treatments implemented in WWTP. Once released in aquatic ecosystems PCPs may cause several adverse effects in the ecological receptors. In this context and considering the dependency of the society on these products, the development of environmentally friendly products, i.e., that exhibit no to low toxicity to the biota, while keeping their high functional efficiency, started to be a priority to several industries. This may be achieved by a directional tunning of specific parts of the structure of chemical compounds. One example is the SoftCAT™ polymers that are used as thickeners by PCPs industry in formulations of hygiene products. These polymers confer specific properties to, for example, shampoos and hair conditioners that are essential for their conditioning, interaction, and deposition performance on the hair. SoftCAT™ consist of a hydroxyethyl cellulose backbone modified with quaternized groups, that may be tuned for its cationic charge (SK variations) and hydrophobic substitutions (HS; SL variations). These modifications alter their capacity to form viscous solutions, their conditioning performance, and antimicrobial properties. However, there is poor information on how such changes in the chemical structure of these polymers may influence their toxicity to the aquatic biota. Though, given their wide use in PCPs, understanding which variant (cationic or HS) is more environmentally friendly, while maintaining its functionally, is of most relevance to guide industry to invest in the development of new formulations using those eco-friendly variations. In this context, the present work aimed at assessing the influence of HS and cationic density modifications in the ecotoxicity of quaternized hydroxyethyl cellulose polymers (SoftCAT™) on aquatic biota, as pristine and after ageing, to identify the most ecofriendly variation. In a first stage, to understand the influence of the polymer’s architecture on the rheological behavior of quaternized hydroxyethyl cellulose polymers, SoftCAT™ polymers with modifications on their charge density (SK variants) and HS (SL variants) were characterized in terms of particle size, zeta potential and rheological properties. From these results, it was observed that the increase of the degree of cationic substitution (SK variants) originated a decrease in the solution viscosity. On the other hand, the increase of HS (SL variants) resulted in an increase in viscosity. Afterwards, the ecotoxicological characterization of SK and SL variants of SoftCAT™ polymers was investigated through a battery of assays using aquatic organisms from different trophic levels (bacteria, microalgae, rotifer, cladocera, ostracod, and fish). For each species the median effective concentration was computed and used to derive hazard concentrations, through the species sensitive distribution curves method. Furthermore, maximum acceptable concentrations were estimated for each variant of the studied polymers to identify the most eco-friendlier. Concerning the polymers with cationic substitutions (SK), the most sensitive species to these types of polymers were the microalga Chlorella vulgaris and the rotifer Brachionus calyciflorus. The variants SKM and SK-MH, presenting intermediate levels of cationic substitution, were revealed to be the least toxic ones comparatively to the variants with lower or higher cationic substitutions. Between these two variants, the SK-M presented the lowest value of the maximum acceptable concentrations (0.00354 mg/L), thus being indicated as the greenest and eco-friendlier SK variant. As for the variants with HS substitution (SL), the two microalgae Raphidocelis subcapitata and C. vulgaris and the rotifer B. calyciflorus were the most sensitive species. It was also observed that the HS influenced the toxicity of these polymers. The variant SL-5 (with less HS) was the least toxic to the species tested, with a maximum acceptable concentration of 14.0 mg/L, thus, being considered the most eco-friendlier SL polymer. Finally, since these contaminants are expected to persist in the aquatic environment for some time, the exposure of the SoftCAT™ polymers after an ageing process of one month at three different temperatures (15, 20, and 25°C) was also assessed to the same six key trophic level species. The obtained results revealed that temperature conditions of ageing influenced differently the toxicity of SK and SL variants. The ageing processes through which SK and SL variants went at the highest temperatures caused a decreased on their toxicity to aquatic biota. However, the temperature of 15°C revealed to increase the toxicity of these polymers, comparatively to the other tested temperatures and to the non-aged variants, for most tested species. For example, at this temperature they caused the mortality of all exposed organisms of B. calyciflorus and Danio rerio species, contrary to the non-aged variants. Of the variants tested with different charge densities, in general, SK-L showed less toxicity after the ageing process at the three temperatures. As for the variants of HS, the SL-30 variant was found to be the least toxic. Thus, in the long term these two variants are considered as a better option to include in PCP formulations as they represent a lower risk for freshwater ecosystems when considering more ecologically relevant and realistic exposure scenarios. Os produtos de cuidados pessoais (PCP) são largamente utilizados nas rotinas diárias, incluindo produtos de limpeza facial, maquilhagem, champôs, amaciadores, produtos de beleza, entre outros. Na composição dos PCPs são usualmente incorporados compostos que podem representar perigos para o ambiente aquático, como por exemplo polímeros catiónicos. Os efluentes das estações de tratamento de águas residuais (ETAR) são considerados como fontes principais de PCP no ambiente aquático, uma vez que muitos destes compostos são resistentes aos tratamentos implementados nas ETAR. Uma vez libertados nos ecossistemas aquáticos, os PCPs podem causar vários efeitos adversos nos recetores ecológicos. Neste contexto e considerando a dependência da sociedade destes produtos, o desenvolvimento de produtos amigos do ambiente, ou seja, que não apresentem ou apresentem baixos riscos para a biota, mantendo a sua elevada eficiência funcional, começou a ser uma prioridade para várias indústrias. Isto pode ser conseguido através do desenho direcionado de partes específicas da estrutura dos compostos químicos. Um exemplo são os polímeros SoftCAT™, que são utilizados como espessantes pela indústria de PCPs em formulações de produtos de higiene. Estes polímeros conferem propriedades específicas a, por exemplo, champôs e condicionadores de cabelo que são essenciais para o seu condicionamento, interação, e desempenho de deposição no cabelo. Os polímeros SoftCAT™ consistem num esqueleto de hidroxietilcelulose modificada com grupos quaternizados, em que as suas cargas catiónicas e substituições hidrofóbicas (HS) podem ser ajustadas. Estas modificações alteram a sua capacidade de formar soluções viscosas, o seu desempenho condicionante, e as suas propriedades antimicrobianas. No entanto, há pouca informação sobre como estas alterações na estrutura química destes polímeros podem influenciar a sua toxicidade no biota aquático. Apesar da sua ampla utilização em PCP, ainda existe pouco conhecimento acerca dos riscos que podem apresentar para os ecossistemas aquáticos, pelo que é pertinente compreender qual a variante (densidade de carga ou HS) é mais amiga do ambiente, mantendo a sua funcionalidade, de modo a orientar a indústria a investir no desenvolvimento de novas formulações utilizando essas variações mais amigas do ambiente. Neste contexto, o presente trabalho visou avaliar a influência de modificações no número de substituições hidrofóbicas e da densidade catiónica, na ecotoxicidade dos polímeros de hidroxietilcelulose quaternizada (SoftCAT™) no ambiente aquático, a fim de identificar a variante mais amiga do ambiente. Numa primeira fase, para compreender a influência da arquitetura do polímero no comportamento reológico dos polímeros de hidroxietilcelulose quaternizada, os polímeros SoftCAT™ com modificações na sua densidade de carga (variantes SK) e HS (variantes SL) foram caracterizados em termos de tamanho de partícula, potencial zeta e propriedades reológicas. A partir destes resultados, observou-se que o aumento do grau de substituição catiónica (variantes SK) deu origem a uma diminuição da viscosidade da solução. Por outro lado, o aumento do HS (variantes SL) resultou num aumento da viscosidade. Posteriormente, a caracterização ecotoxicológica das variantes SK e SL de polímeros SoftCAT™ foi investigada através da realização de ensaios ecotoxicológicos utilizando organismos aquáticos de diferentes níveis tróficos (bactérias, microalgas, rotíferos, cladocera, ostracodes e peixes). Para cada espécie foi determinada a concentração mediana efetiva que foi utilizada para derivar concentrações de perigo, através do método das curvas de distribuição de sensibilidades das espécies. Além disso, foram determinadas concentrações máximas aceitáveis no ambiente para cada variante dos polímeros estudados, a fim de identificar qual a arquitetura menos prejudicial. Relativamente aos polímeros com substituições catiónicas (SK), as espécies mais sensíveis a estes tipos de polímeros foram a microalga Chlorella vulgaris e o rotífero Brachionus calyciflorus. As variantes SK-M e SK-MH, apresentando níveis intermédios de substituição catiónica, revelaram-se como as menos tóxicas comparativamente às variantes com substituições catiónicas inferiores ou superiores. Entre estas duas variantes, a SK-M apresentou o valor mais baixo das concentrações máximas aceitáveis (0,00354 mg/L), sendo assim indicada como a variante SK mais amiga do ambiente. Quanto às variantes com substituição diferentes HS (SL), as duas microalgas Raphidocelis subcapitata e C. vulgaris e o rotífero Brachionus calyciflorus foram as espécies mais sensíveis. Foi também observado que a substituição hidrofóbica influenciou a toxicidade destes polímeros. A variante SL-5 (com menos HS) revelou ser a menos tóxica para as espécies testadas, com uma concentração máxima aceitável de 14,0 mg/L, sendo assim, considerada a variante SL mais amiga do ambiente. Finalmente, uma vez que se espera que estes contaminantes persistam no ambiente aquático durante algum tempo, a exposição dos polímeros SoftCAT™ após um processo de envelhecimento de um mês a três temperaturas diferentes (15, 20, e 25°C) foi também avaliada para as mesmas seis espécies-chave de cada nível trófico. Os resultados obtidos revelaram que as condições de temperatura do envelhecimento influenciaram de forma diferente a toxicidade das variantes SK e SL. Os processos de envelhecimento através dos quais as variantes SK e SL foram submetidas nas temperaturas mais elevadas causaram uma diminuição da sua toxicidade para a biota aquática. Contudo, de um modo geral a temperatura de 15°C revelou aumentar a toxicidade destes polímeros, comparativamente às outras temperaturas testadas e às variantes correspondentes não envelhecidas. Por exemplo, a maioria das variantes SL expostas a 15°C causaram a mortalidade da maioria dos organismos expostos das espécies B. calyciflorus e Danio rerio, ao contrário das variantes não envelhecidas. Das variantes testadas com diferentes densidades de carga, de um modo geral a SK-L revelou menor toxicidade após o processo de envelhecimento nas três temperaturas. No que respeita às variantes em que se variou a HS, a variante SL-30 foi a que revelou ser menos tóxica. Deste modo, a longo prazo estas variantes são consideradas como a melhor opção a incluir nas formulações de PCPs, pois constituem um menor risco para os ecossistemas dulçaquícolas tendo em consideração cenários de exposição ecologicamente relevantes e reais. Programa Doutoral em Biologia

The photocatalytic oxidation (PCO) of pollutants using TiO2-based materials can significantly improve indoor air quality (IAQ), which in turn, has a significant impact on human health and life expectancy. TiO2-based nanoparticles (NPs) are widely used as part of building materials to function as photocatalysts in PCO. In this work, a series of sulfur-doped TiO2 NPs immobilized on a silica matrix were synthesized by combining a sol-gel process with ball milling. The samples were structurally characterized by X-ray diffraction (XRD), UV-Vis diffuse reflectance spectroscopy (DRS), Fourier-transform infrared spectroscopy (FT-IR) and N2 adsorption-desorption isotherms. Furthermore, the morphological characteristics were determined by dynamic light scattering (DLS), scanning electron microscopy (SEM) and transmission electron microscopy (TEM). The photocatalytic activity of the as prepared S-doped TiO2/SiO2 NPs in the degradation of liquid and air pollutants under visible-light irradiation was investigated. Our results show that sulfur is an effective dopant for activating TiO2/SiO2 photocatalysts under visible-light irradiation. Silica constitutes a “safe-by-design” approach and inhibits the aggregation of NPs during synthesis. The most efficient photocatalyst afforded 79% removal of methyl orange (5 h), 26% removal of acetaldehyde (1 h) and 12% oxidation of NO (1 h).

PhD course ‘Safe by Design’

In this paper, we explore solution directions for the implementation of Safe by Design (SbD) in safety regimes for academic experimentation. SbD is a dynamic and anticipatory strategy for safety regulation in academic research. In this strategy, safety is taken in a broader sense including not only issues of technical precaution of avoiding risks of experimentation but also the societal responsibility of researchers and research institutes of identifying possible future risks. In our research, we have interviewed academic researchers from different disciplines and university support personnel about the factors that enable and limit the possibilities of researchers to implement SbD in safety regimes for experimentation. We articulate our findings in terms of a core set of research values and in terms of conflicts between safety and these research values. And we argue that tools for resolving value conflicts as originating in design for values research can provide directions to solve the value conflicts, and thus help academic researchers to adopt SbD in their experimentation.

International audience; Moving towards safe and sustainable innovations is an international policy ambition. In the on-hand manuscript, a concept combining safe by design and sustainability was implemented through the integration of human and environmental risk assessment, life cycle assessment as well as an assessment of the economic viability. The result is a nested and iterative process in form of a decision tree that integrates these three elements in order to achieve sustainable, safe and competitive materials, products or services. This approach, embedded into the stage-gate-model for safe by design, allows to reduce the uncertainty related to the assessment of risks and impacts by improving the quality of the data collected along each stage. In the second part of the manuscript, the application is shown for a case study dealing with the application of nanoparticles for Li-Ion batteries. One of the general conclusions out of this case study is that data gaps are a key aspect in view of the reliability of the results.

Sunscreens are of emerging concern regarding environmental effect. After leaving the skin either through bathing or washing, the ingredients contained in the product formulation can be released into rivers, lakes, seashores, and/or sewage treatment plants. Nanomaterials used as UV-filters are of particular concern in this context as they may have a negative effect on these systems. To assess the risks posed, the exposure and hazard of nanoparticulate UV-filters must be considered through the entire lifecycle of the sunscreen product. This includes not only usage, but also manufacturing and disposal at the end of life of the product, as some nanomaterials may be released into the environment at each stage. This includes also developing relevant approaches that take into account realistic scenarios of environmental release and fate. Nanoparticulate UV-filters typically consist of a mineral nanoparticle core (TiO2 or ZnO) coated with surface layers aimed at optimizing the dispersion in the formulation and at supressing any photo-sensibility. This coating plays a key role in the associated risk since it affects the nanoparticle surface properties, which control both fate and hazard. At present, knowledge gaps remain regarding the safety of nanomaterials used in sunscreen, as very few studies have focused on real sunscreen filters and formulations throughout their lifecycle so far. A literature review is proposed here from the design of nanoparticulate UV-filters and formulations, to the release, fate, and effect in the different compartments encountered along the product lifecycle. The resulting state of the art highlights knowledge gaps and will likely help regulators, manufacturers, and consumers choose appropriate guidance. By considering each development stage of the sunscreen, from the choice of the UV-filter(s) and its (their) integration into a cosmetic formulation to the knowledge of the risk involved in this choice all along the product lifecycle, an eco-design approach can be achieved where release or toxicity are reduced. Sustainability can thus be accounted for, during the design process, by making the appropriate choices (in advance) that help minimize or prevent the environmental impact of the sunscreen.

Efficacy and safety of nanomedicines based on polymeric (bio)materials will benefit from a rational implementation of a Safe-by-Design (SbD) approach throughout their development. In order to achieve this goal, however, a standardization of preparation and characterization methods and their accurate reporting is needed. Focusing on the example of chitosan, a biopolymer derived from chitin and frequently used in drug and vaccine delivery vector preparation, this review discusses the challenges still to be met and overcome prior to a successful implementation of the SbD approach to the preparation of chitosan-based protein drug delivery systems.

International audience; Based on fieldwork, this article highlights the unexpected effects of controversies about nanotechnology in France. These controversies stem in particular from a strong challenge to the field by civil society protests and criticism concerning environmental and health risks. One reason for this challenge is the specific difficulties in assessing the toxicity and ecotoxicity of nanomaterials. Civil society organizations have pushed for strictly controlling or stopping academic, industrial, or even basic research. They were not successful in this regard but their activities prompted researchers to think about “safe by design” solutions and this led to new interdisciplinary cooperation. Furthermore, the uncertainty about the risks assessment resulted in a reconfiguration of the relationship between academic research and industrial companies. Researchers have become essential to the shaping of safe products. The risks of nanomaterials have thus been a driving force for new research and innovation practices.

Submitted by JOSIANE SANTOS DE OLIVEIRA (josianeso) on 2018-05-11T15:13:54Z No. of bitstreams: 1 Raquel Von Hohendorff_.pdf: 10228081 bytes, checksum: f4227256dee4ed80e5dd7d192e5b4481 (MD5) Made available in DSpace on 2018-05-11T15:13:54Z (GMT). No. of bitstreams: 1 Raquel Von Hohendorff_.pdf: 10228081 bytes, checksum: f4227256dee4ed80e5dd7d192e5b4481 (MD5) Previous issue date: 2018-03-16 CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior Esta Tese tem como tema a gestão dos riscos nanotecnológicos com foco na autorregulação a partir do safe by design, em busca dos objetivos de sustentabilidade do milênio, no contexto da improbabilidade da comunicação inter-sistêmica entre o Direito e Ciência. Atualmente a ampliação do uso das nanotecnologias é uma das principais novidades que vem ocorrendo no setor de produção no mundo inteiro, fazendo parte da Quarta Revolução Industrial, trazendo conjuntamente uma série de preocupações em relação aos aspectos éticos, legais e sociais, bem como acerca dos riscos à saúde e ao meio ambiente. Cabe lembrar que as mesmas características que tornam os nanomateriais diferenciados e benéficos também geram dúvidas e inquietações acerca de seu comportamento especialmente quanto a sua interação com o ecossistema. Em decorrência desta nova realidade, provocada pela ascensão nanotecnológica e seus potenciais riscos, especialmente em relação à saúde humana e ao meio ambiente objetivou-se analisar as possibilidades da contribuição da ferramenta do safe by design, como uma forma de acoplamento entre o Sistema do Direito e o Sistema da Ciência, permeada pelo conceito de pesquisa e inovação responsáveis Responsible Research and Innovation (RRI), preocupada também com os aspectos éticos, sociais e jurídicos - Ethical, Legal and Social Aspects (ELSA), na estruturação autorregulatória regulada da gestão dos riscos nanotecnológicos, visando a sustentabilidade, em seus diferentes aspectos, aplicada à inovação, no contexto dos Objetivos de Desenvolvimento do milênio, projetados pela Organizações das Nações Unidas (ONU) até 2030. Para tanto, utilizou-se a perspectiva metodológica sistêmico-construtivista, a partir das contribuições de Niklas Luhmann, Gunther Teubner e Leonel Severo Rocha, que considera a realidade como uma construção de um observador, analisando todas as peculiaridades implicadas na observação, tratando-se de uma forma de reflexão jurídica sobre as próprias condições de produção de sentido, bem como as possibilidades de compreensão das múltiplas dinâmicas comunicativas diferenciadas em um ambiente complexo, como é o gerado pelas nanotecnologias. Desta forma, o safe by design pode ser entendido como um possível acoplamento estrutural entre os Sistemas da Ciência e do Direito, potencializando a comunicação inter-sistêmica sobre o risco, como uma forma prática e criativa de aplicação das ideias de RRI e ELSA e, mais ainda, como uma modalidade de autorregulação regulada, na gestão dos riscos nanotecnológicos, organizando e estabilizando as expectativas e induzindo comportamentos em busca da sustentabilidade na inovação, no horizonte projetado pelos Objetivos de Sustentabilidade do Milênio. Assim, demonstra-se a necessária imersão do Sistema do Direito na observação sobre risco nanotecnológico, contribuindo com mais um passo rumo à discussão das possibilidades e desafios que o uso das nanotecnologias já está gerando para as atuais e futuras gerações. This Thesis deals with nanotechnological risk management with a focus on self-regulation based on safe by design, in pursuit of the millennium sustainability goals, in the context of the improbability of inter-systemic communication between Law and Science. Currently, the expansion of the use of nanotechnologies is one of the main innovations that occurring in the production sector worldwide, as part of the Fourth Industrial Revolution, bringing together a number of concerns regarding ethical, legal and social aspects, as well as the risks to health and environment. It should be remembered that the same characteristics, which make nanomaterials differentiated and beneficial, also generate doubts and concerns about their behavior especially regarding their interaction with the ecosystem. As a result of this new reality, provoked by the rise in nanotechnology and its potential risks, especially in relation to human health and environment, the objective was to analyze the possibilities of the contribution of the safe by design tool as a form of coupling between the Law System and the Science System, permeated by the concept of Responsible Research and Innovation (RRI), which is also concerned with - Ethical, Social and Legal Aspects (ELSA), in the self-regulatory structuring of nanotechnology risk management, aiming at the sustainability, in its different aspects, applied to innovation, in the context of the Millennium Development Goals, projected by the UN until 2030. For that, the systemic-constructivist methodological perspective was used, based on the contributions of Niklas Luhmann, Gunther Teubner and Leonel Severo Rocha, considering reality as a construction of an observer, analyzing all the peculiarities involved in the observation, treating it is a form of juridical reflection on the conditions of production of meaning as well as the possibilities of understanding the multiple differentiated communicative dynamics in a complex environment, such as that generated by nanotechnologies. In this way, safe by design can be understood as a possible structural coupling between the Systems of Science and Law, enhancing inter-systemic communication about risk as a practical and creative way of applying the ideas of RRI and ELSA, moreover, as a modality of regulated self-regulation, in the management of nanotechnology risks, organizing and stabilizing expectations and inducing behaviors in search of sustainability in innovation, within the horizon projected by the Millennium Sustainability Goals. Thus, it is demonstrated the necessary immersion of the Law System in the observation on nanotechnological risk, contributing with one more step towards the discussion of the possibilities and challenges that the use of nanotechnologies is already generating for the present and future generations.

The spread of infections in healthcare environments is a persistent and growing problem in most countries, aggravated by the development of microbial resistance to antibiotics and disinfectants. In addition to indwelling medical devices (e.g. implants, catheters), such infections may also result from adhesion of microbes either to external solid-water interfaces such as shower caps, taps, drains, etc., or to external solid-gas interfaces such as door handles, clothes, curtains, computer keyboards, etc. The latter are the main focus of the present work, where an overview of antimicrobial coatings for such applications is presented. This review addresses well-established and novel methodologies, including chemical and physical functional modification of surfaces to reduce microbial contamination, as well as the potential risks associated with the implementation of such anti-contamination measures. Different chemistry-based approaches are discussed, for instance anti-adhesive surfaces (e.g. superhydrophobic, zwitterions), contact-killing surfaces (e.g. polymer brushes, phages), and biocide-releasing surfaces (e.g. triggered release, quorum sensing-based systems). The review also assesses the impact of topographical modifications at distinct dimensions (micrometre and nanometre orders of magnitude) and the importance of applying safe-by-design criteria (e.g. toxicity, contribution for unwanted acquisition of antimicrobial resistance, long-term stability) when developing and implementing antimicrobial surfaces. (C) 2018 The Author(s). Published by Elsevier Ltd on behalf of The Healthcare Infection Society.

Migration due to indirect contact with packaging caused several major sanitary crises, including the spread contamination of dry food by mineral oils and printing ink constituents from cardboard. The issues are still not fully resolved because the mechanisms have been insufficiently described and the relationship between design, contamination level, type of contaminant, and conditions of storage (time and temperature) are poorly understood. This study proposes a forensic analysis of these phenomena when food is separated from cardboard by a plastic layer. Practical relationships and advanced simulation scenarios were devised and validated against the long-term migration between 20 and 60°C of 15 substances. They were chosen to be representative of the main contaminants of cardboard: aliphatic and aromatic mineral oils, photo-initiators and plasticisers. Data were summarised as iso-contamination curves and iso-contamination times up to 2 years. Simple rules are illustrated to extrapolate the results to arbitrary conditions in order to identify critical substances and to estimate the plastic film's thickness to keep the contamination within acceptable limits. Recommendations for the risk management of contamination routes without contact are finally drafted.

Nano-products and nano-enabled applications need a clear and easy-to-follow human and environmental safety framework for the development along the innovation chain from initial idea to market and beyond that facilitates navigation through the complex regulatory and approval processes under which different product categories fall. The missing framework results in a lack of (i) solid data regarding roadblocks to market penetration of nano-enabled products as well as the absence of (ii) transparency in terms of which products (e.g. containing nanomaterials (NMs); nano-enabled products) are on the market (e.g. registries) and voluntary schemes and labelling requirements for cosmetics and food, which processes are used for manufacturing nano-enabled products, and (iii) meager inclusiveness in the dialogue (between all stakeholders) most likely exist as a result of the missing framework. The Closer-to-the-Market-Roadmap (abbrev. CTTM) aims at speeding up the progress towards market implementation of nanotechnologies by outlining the steps needed to develop such a framework. In its current form it is addressed towards policy makers, but the ultimate framework will be designed for use by SME and enterprise organisations. The CTTM identifies the key challenges to be tackled immediately and outlines a stepby-step approach to establishing a framework to deliver of nano-enabled products to the market: (i) building an inclusive collaboration network, (ii) bringing together the scientific and entrepreneurial experts, (iii) strengthening dialogue of all stakeholders (inclusiveness!) and exchange to raise synergies and safe resources, (iv) implementing of a novel risk assessment framework supported by the regulatory initiatives and implemented by contract research organisations, and (v) building service provider platforms which function as consulting agencies assisting companies to bring their products towards market implementation. Along these actions, the respective skillset development, educational training and formation of job profiles and recognition certificates shall be established. The accompanying tasks will be to continue the dialogue (e.g. risk communication, safety awareness, dissemination dialogue, needs assessment, debate on key topics, consultation on proposed activities/solutions, etc.) with different stakeholder groups (such as e.g. public authorities, broad public, opinion leaders, NGO´s, etc.) with the objective to increase the level of information via visualization and communication, in order to address all the current gaps listed within the CTTM. This will enable a transparent and open communication process. Along with facilitating the market implementation of nano-products and nano-enabled applications, the consumers and end users of these products shall be provided with a clear and validated declaration regarding the use and function of NMs in products. Such information will show, in a balanced and standardized way the risks and benefits of the nano-enabled vs. the previously established products and of course addressing the unique new products and applications enabled by nanotechnology. This will increase understanding (and potentially support building trust) among stakeholders about safety issues, reduce the uncertainties for SMEs and enterprises about how to address the nanoenabled products (and NMs) properly, and minimise the impact of risk and safety assessment processes on hampering the innovation potential. Following the recommendations of the EU REACH system (Article 13) and regarding ethical aspects, the risk assessment procedures should be performed with possible CTTM_NSC_Roadmap_final_for_NSC 7 reduction of living animals’ use. Whenever possible, alternative methods such as in vitro and in silico (computational) testing should be applied for replacing experiments with higher animals. Moreover, the use of computational modelling for supporting Safer-byDesign (SbD) and High Throughput Screening (HTS) might be an interesting option for the innovative industry, since it enables to extend the number of considered solutions without increasing costs. The actions proposed in the CTTM will reduce the uncertainties for all stakeholders, increase the safety of nano-enabled products while reducing their time to market, and increase the market confidence in this technology and the acceptance of the safe nanoenabled products by businesses and consumers.

With new threats endangering the safety of substations, critical infrastructure protection in substations has come to include sniper fire, ballistics and blast protection. Safe by Design approach allows that all types of design safety and performance criteria – fire, blast, impact, wind – cross over from safety to security. In this article Critical Infrastructure Protection innovations and strategy options are discussed, with a focus on ballistic fire barriers that provide both safety and security at critical facilities.

The knowledge on potential harmful effects of metallic nanomaterials lags behind their increased use in consumer products and therefore, the safety data on various nanomaterials applicable for risk assessment are urgently needed. In this study, 11 metal oxide nanoparticles (MeOx NPs) prepared using flame pyrolysis method were analyzed for their toxicity against human alveolar epithelial cells A549, human epithelial colorectal cells Caco2 and murine fibroblast cell line Balb/c 3T3. The cell lines were exposed for 24 h to suspensions of 3-100 μg/mL MeOx NPs and cellular viability was evaluated using. Neutral Red Uptake (NRU) assay. In parallel to NPs, toxicity of soluble salts of respective metals was analyzed, to reveal the possible cellular effects of metal ions shedding from the NPs. The potency of MeOx to produce reactive oxygen species was evaluated in the cell-free assay. The used three cell lines showed comparable toxicity responses to NPs and their metal ion counterparts in the current test setting. Six MeOx NPs (Al2O3, Fe3O4, MgO, SiO2, TiO2, WO3) did not show toxic effects below 100 μg/mL. For five MeOx NPs, the averaged 24 h IC50 values for the three mammalian cell lines were 16.4 μg/mL for CuO, 22.4 μg/mL for ZnO, 57.3 μg/mL for Sb2O3, 132.3 μg/mL for Mn3O4 and 129 μg/mL for Co3O4. Comparison of the dissolution level of MeOx and the toxicity of soluble salts allowed to conclude that the toxicity of CuO, ZnO and Sb2O3 NPs was driven by release of metal ions. The toxic effects of Mn3O4 and Co3O4 could be attributed to the ROS-inducing ability of these NPs. All the NPs were internalized by the cells according to light microscopy studies but also proven by TEM, and internalization of Co3O4 NPs seemed to be most prominent in this aspect. In conclusion, this work provides valuable toxicological data for a library of 11 MeOx NPs. Combining the knowledge on toxic or non-toxic nature of nanomaterials may be used for safe-by-design approach. Refereed/Peer-reviewed