Environmental considerations and current status of grouping and regulation of engineered nanomaterials

This article reviews the current status of nanotechnology with emphasis on application and related environmental considerations as well as legislation. Application and analysis of nanomaterials in infrastructure (construction, building coatings, and water treatment) is discussed, and in particular nanomaterial release during the lifecycle of these applications. Moreover, possible grouping approaches with regard to ecotoxicological and toxicological properties, and the fate of nanomaterials in the environment are evaluated. In terms of potential exposure, the opportunities that arise from leveraging advances in several key areas, such as water treatment and construction are addressed. Additionally, this review describes challenges with regard to the European Commission’s definition of ‘nanomaterial’. The revised REACH information requirements, intended to enable a comprehensive risk assessment of nanomaterials, are outlined

Analytical and toxicological aspects of nanomaterials in different product groups: Challenges and opportunities

The widespread integration of engineered nanomaterials into consumer and industrial products creates new challenges and requires innovative approaches in terms of design, testing, reliability, and safety of nanotechnology. The aim of this review article is to give an overview of different product groups in which nanomaterials are present and outline their safety aspects for consumers. Here, release of nanomaterials and related analytical challenges and solutions as well as toxicological considerations, such as dose-metrics, are discussed. Additionally, the utilization of engineered nanomaterials as pharmaceuticals or nutraceuticals to deliver and release cargo molecules is covered. Furthermore, critical pathways for human exposure to nanomaterials, namely inhalation and ingestion, are discussed in the context of risk assessment. Analysis of NMs in food, innovative medicine or food contact materials is discussed. Specific focus is on the presence and release of nanomaterials, including whether nanomaterials can migrate from polymer nanocomposites used in food contact materials. With regard to the toxicology and toxicokinetics of nanomaterials, aspects of dose metrics of inhalation toxicity as well as ingestion toxicology and comparison between in vitro and in vivo conclusions are considered. The definition of dose descriptors to be applied in toxicological testing is emphasized. In relation to potential exposure from different products, opportunities arising from the use of advanced analytical techniques in more unique scenarios such as release of nanomaterials from medical devices such as orthopedic implants are addressed. Alongside higher product performance and complexity, further challenges regarding material characterization and safety, as well as acceptance by the general public are expected

Exploring Adverse Outcome Pathways for Nanomaterials with semantic web technologies

Adverse Outcome Pathways (AOPs) have been proposed to facilitate mechanistic understanding of interactions of chemicals/materials with biological systems. Each AOP starts with a molecular initiating event (MIE) and possibly ends with adverse outcome(s) (AOs) via a series of key events (KEs). So far, the interaction of engineered nanomaterials (ENMs) with biomolecules, biomembranes, cells, and biological structures, in general, is not yet fully elucidated yet. There is also a huge lack of information on which AOPs are ENMs-relevant or -specific, despite numerous published data on toxicological endpoints they trigger, such as oxidative stress and inflammation. We propose to integrate related data and knowledge recently collected. Our approach combines the annotation of nanomaterials and their MIEs with ontology annotation to demonstrate how we can then query AOPs and biological pathway information for these materials. We conclude that a FAIR (Findable, Accessible, Interoperable, Reusable) representation of the ENM-MIE knowledge simplifies integration with other knowledge

Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report

From Crossref journal articles via Jisc Publications RouterHistory: epub 2023-05-26, issued 2023-05-26Article version: AMPublication status: PublishedGenotoxicity testing for nanomaterials remains challenging as standard testing approaches require some adaptation, and further development of nano-specific OECD Test Guidelines (TGs) and Guidance Documents (GDs) are needed. However, the field of genotoxicology continues to progress and new approach methodologies (NAMs) are being developed that could provide relevant information on the range of mechanisms of genotoxic action that may be imparted by nanomaterials. There is a recognition of the need for implementation of new and/or adapted OECD TGs, new OECD GDs and utilisation of NAMs within a genotoxicity testing framework for nanomaterials. As such, the requirements to apply new experimental approaches and data for genotoxicity assessment of nanomaterials in a regulatory context is neither clear, nor used in practice. Thus, an international workshop with representatives from regulatory agencies, industry, government, and academic scientists was convened to discuss these issues. The expert discussion highlighted the current deficiencies that exist in standard testing approaches within exposure regimes, insufficient physico-chemical characterisation, lack of demonstration of cell or tissue uptake and internalisation, and limitations in the coverage of genotoxic modes of action. Regarding the latter aspect, a consensus was reached on the importance of using NAMs to support the genotoxicity assessment of nanomaterials. Also highlighted was the need for close engagement between scientists and regulators to 1) provide clarity on the regulatory needs, 2) improve the acceptance and use of NAMs-generated data, and 3) define how NAMs may be used as part of Weight of Evidence approaches for use in regulatory risk assessments

Nanomaterials: certain aspects of application, risk assessment and risk communication

Development and market introduction of new nanomaterials trigger the need for an adequate risk assessment of such products alongside suitable risk communication measures. Current application of classical and new nanomaterials is analyzed in context of regulatory requirements and standardization for chemicals, food and consumer products. The challenges of nanomaterial characterization as the main bottleneck of risk assessment and regulation are presented. In some areas, e.g., quantification of nanomaterials within complex matrices, the establishment and adaptation of analytical techniques such as laser ablation inductively coupled plasma mass spectrometry and others are potentially suited to meet the requirements. As an example, we here provide an approach for the reliable characterization of human exposure to nanomaterials resulting from food packaging. Furthermore, results of nanomaterial toxicity and ecotoxicity testing are discussed, with concluding key criteria such as solubility and fiber rigidity as important parameters to be considered in material development and regulation. Although an analysis of the public opinion has revealed a distinguished rating depending on the particular field of application, a rather positive perception of nanotechnology could be ascertained for the German public in general. An improvement of material characterization in both toxicological testing as well as end-product control was concluded as being the main obstacle to ensure not only safe use of materials, but also wide acceptance of this and any novel technology in the general public.JRC.F.2-Consumer Products Safet

COLNACOQ. Composés lipophiles naturels dans l’environnement des coquillages. Rapport final

Cette étude s’est inscrite dans un contexte d’évaluation de la salubrité des mollusques bivalves destinés à la consommation humaine. Ces organismes peuvent en effet accumuler des toxines, en particulier de microalgues, en concentrations importantes, pouvant induire des intoxications chez les personnes les consommant. Afin d’assurer la protection des consommateurs, les toxines réglementées sont recherchées dans les coquillages par techniques physico-chimiques. En parallèle, les toxines émergentes, potentiellement produites par d’autres organismes que les micro-algues telles que les micromycètes, peuvent être detectées par l’utilisation du test de toxicité aigüe sur souris. Cependant, ce bio-essai présente de très nombreux inconvénients, notamment éthiques et méthodologiques. C’est pourquoi une suite de bio-essais miniaturisés a été développée en utilisant trois types de tests : cytotoxicité sur cellules KB, la toxicité aguë sur larves de diptères, et activités antibactériennes sur bactéries marines. Ces tests ont dans un premier temps été adaptés à des protocoles de routine, puis leur périmètre de détection a été évalué à différents niveaux de complexité de la matrice : toxine lipophile pure connue ou émergente, extrait brut de micro-algue ou de micromycète producteur de toxine, et matrices de bivalves dopées par des toxines. Les trois tests se sont révélés être complémentaires dans leurs champs de détection, et une démarche pour leur mise en place a pu été proposée. Une douzaine de souches de microalgues et 24 souches de micromycètes ont été cultivées et testées avec la suite de bio-essais. Pour certaines souches de micro-algues et de micromycètes de nouveaux composés ont pu être mis en évidence. En s’appuyant sur des techniques de spectrométrie de masse haute résolution, des exercices de déréplication ont été entrepris pour deux organismes en particulier : le dinoflagellé Vulcanodinium rugosum et le micromycète Beauveria brongniartii. La procédure développée a été validée pour la matrice coquillage et pourra de ce fait être utilisé dans le cadre de recherche de composés toxiques dans cette matrice, notamment dans les dispositifs nationaux de vigilance alimentaire

Simultaneous Quantification and Visualization of Titanium Dioxide Nanomaterial Uptake at the Single Cell Level in an In Vitro Model of the Human Small Intestine

Useful properties render titanium dioxide nanomaterials (NMs) to be one of the most commonly used NMs worldwide. TiO2 powder is used as food additives (E171), which may contain up to 36% nanoparticles. Consequently, humans could be exposed to comparatively high amounts of NMs that may induce adverse effects of chronic exposure conditions. Visualization and quantification of cellular NM uptake as well as their interactions with biomolecules within cells are key issues regarding risk assessment. Advanced quantitative imaging tools for NM detection within biological environments are therefore required. A combination of the label-free spatially resolved dosimetric tools, microresolved particle induced X-ray emission and Rutherford backscattering, together with high resolution imaging techniques, such as time-of-flight secondary ion mass spectrometry and transmission electron microscopy, are applied to visualize the cellular translocation pattern of TiO2 NMs and to quantify the NM-load, cellular major, and trace elements in differentiated Caco-2 cells as a function of their surface properties at the single cell level. Internalized NMs are not only able to impair the cellular homeostasis by themselves, but also to induce an intracellular redistribution of metabolically relevant elements such as phosphorus, sulfur, iron, and copper

EFSA Project on the use of New Approach Methodologies (NAMs) for the hazard assessment of nanofibres. Lot 1, nanocellulose oral exposure: gastrointestinal digestion, nanofibres uptake and local effects

Question number: EFSA-Q-2023-00528International audienceNanocellulose (NC) is an emerging material in the food sector with several prospective application areas. Three main types of NC exist, i.e. bacterial NC (BNC), nanofibrillated cellulose (NFC), and cellulose nanocrystals (CNC). The biological sources and processing conditions affect several physicochemical parameters of NC. In the present project, a NAM-based IATA for addressing data gaps in the assessment of potential hazards associated to NC oral exposure was considered. This IATA focused on three main pillars, i.e. (i) assessment of the uptake and potential crossing of the intestinal barrier by NC, (ii) assessment of local effects, including inflammation and genotoxicity, on the gastrointestinal epithelia, and (iii) assessment of any digestion or degradation of NC by the human microbiome. Eight NC samples belonging to the three NC types, plus a comparator in the micro-range, were selected as study materials and EFSA NAMs Project on Nanofibres, Lot 1 www.efsa.europa.eu/publications EFSA Supporting publication 2023:EN-8258 2 submitted to a thorough physicochemical characterisation. A battery of in vitro tests was used to provide insight into NC hazard and mode of action according to a tiered approach, which lead to selection of three materials belonging to the three main NC types for in depth-testing. Cell uptake of these materials was demonstrated, and such uptake was greater in a triculture model, which better simulates the barrier properties of the human intestinal epithelium, as compared to Caco-2 monolayers. Uptake was the greatest in repeated exposure conditions, in which intestinal barrier crossing was demonstrated for CNC. Pro-inflammatory responses accompanied by massive NC uptake in macrophages, indicative for potential immunotoxicological effects, and barrier function impairment were observed, whereas no indications for genotoxicity were obtained. Finally, no formation of smaller particles following colonic fermentation of NC was observed. For the integration of these results in regulatory hazard assessment of NC after oral exposure, prospective use of NC as novel food or as food additive was considered