Regulatory preparedness for multicomponent nanomaterials: Current state, gaps and challenges of REACH.

In 2018 the European Commission adopted revisions to the Annexes of Regulation (EC) No 1907/2006 concerning registration, evaluation, authorisation and restriction of chemicals (REACH) to introduce nanomaterial-specific clarifications and provisions. Multicomponent nanomaterial (MCNM) is a non-regulatory term that has been used in recent EU-funded projects to describe nanomaterials with a complex structure and/or composition and which are expected to be increasingly used in products in the near future. This paper examines the regulatory preparedness of REACH, and its revised Annexes, for MCNMs.

Detecting Sensitive Spectral Bands and Vegetation Indices for Potato Yield Using Handheld Spectroradiometer Data.

Remote sensing is a valuable tool in precision agriculture due to its spatial and temporal coverage, non-destructive method of data collection, and cost-effectiveness. In this study, we measured the canopy reflectance of potato ( L.) crops on a plant-by-plant basis with a handheld spectrometer instrument.

Intrinsic-dimension analysis for guiding dimensionality reduction and data fusion in multi-omics data processing.

Multi-omics data have revolutionized biomedical research by providing a comprehensive understanding of biological systems and the molecular mechanisms of disease development. However, analyzing multi-omics data is challenging due to high dimensionality and limited sample sizes, necessitating proper data-reduction pipelines to ensure reliable analyses. Additionally, its multimodal nature requires effective data-integration pipelines.

A European aerosol phenomenology - 9: Light absorption properties of carbonaceous aerosol particles across surface Europe.

Carbonaceous aerosols (CA), composed of black carbon (BC) and organic matter (OM), significantly impact the climate. Light absorption properties of CA, particularly of BC and brown carbon (BrC), are crucial due to their contribution to global and regional warming. We present the absorption properties of BC (b) and BrC (b) inferred using Aethalometer data from 44 European sites covering different environments (traffic (TR), urban (UB), suburban (SUB), regional background (RB) and mountain (M)).

Empirical estimation of disutilities and decision thresholds for composite endpoints.

Objective: The evaluation of health benefits and harms of an intervention with GRADE Evidence to Decision (EtD) frameworks includes judgments if the effects are "trivial", "small", "moderate" or "large". Such judgments ideally require the a priori establishment of decision thresholds (DTs), whose empirical derivation for single outcomes has been previously described. In this article, we provide a methodological approach to estimate DTs for composite endpoints based on disutilities.

Novel strategies to assess cytokine release mediated by chimeric antigen receptor T cells based on the adverse outcome pathway concept.

The success of cellular immunotherapies such as chimeric antigen receptor (CAR) T cell therapy has led to their implementation as a revolutionary treatment option for cancer patients. However, the safe translation of such novel immunotherapies, from non-clinical assessment to first-in-human studies is still hampered by the lack of suitable and models recapitulating the complexity of the human immune system. Additionally, using cells derived from human healthy volunteers in such test systems may not adequately reflect the altered state of the patient's immune system thus potentially underestimating the risk of life-threatening conditions, such as cytokine release syndrome (CRS) following CAR T cell therapy.

An overview of immune safety avatar: mimicking the effects of immunomodulatory therapies on the immune system.

Innovative therapeutics like biologicals that modulate the immune system are on the rise. However, their immune-modulating characteristics can also lead sometimes to the induction of adverse effects, by triggering unintended immune reactions. Due to the complexity and target-specificity of such therapeutics, these drug-induced adverse events could remain undetected during non-clinical development, if the test systems are, for example, animal-based, and only emerge in clinical development when tested in humans and subsequently lead to discontinuance of otherwise promising drug candidates.

High-throughput phenotyping using hyperspectral indicators supports the genetic dissection of yield in durum wheat grown under heat and drought stress.

High-throughput phenotyping (HTP) provides new opportunities for efficiently dissecting the genetic basis of drought-adaptive traits, which is essential in current wheat breeding programs. The combined use of HTP and genome-wide association (GWAS) approaches has been useful in the assessment of complex traits such as yield, under field stress conditions including heat and drought. The aim of this study was to identify molecular markers associated with yield (YLD) in elite durum wheat that could be explained using hyperspectral indices (HSIs) under drought field conditions in Mediterranean environments in Southern Spain.

Quantifying residents' exposure to agricultural pesticides using new geospatial approaches.

A better understanding of environmental exposure to agricultural pesticides is crucial for public health, regulatory and management purposes. Residents in close vicinity to agricultural fields are likely to be more exposed to pesticides. In that context, an innovative geospatial approach for mapping estimates of agricultural pesticide exposure was developed in this study.

Characterization of Phytoplankton Composition in Lake Maggiore: Integrated Chemotaxonomy for Enhanced Cyanobacteria Detection.

Cyanobacterial blooms in lakes have increased in frequency and intensity over the past two decades, negatively affecting ecological and biogeochemical processes. This study focuses on the phytoplankton composition of Lake Maggiore, with a special emphasis on cyanobacteria detection through pigment composition. While microscopy is the standard method for phytoplankton identification, pigment-based methods provide broader spatiotemporal coverage.

Within-host dynamics of antiviral treatment with remdesivir for SARS-CoV-2 infection.

The effectiveness of antiviral treatment with remdesivir against COVID-19 has been investigated in clinical trials suggesting earlier recovery. However, this effect seems to be rather modest. In this study, we tracked the clinical course of SARS-CoV-2 infections in 369 COVID-19 individuals across a spectrum of illness severities, including both untreated individuals and individuals who received antiviral treatment with remdesivir.

Source apportionment of ultrafine particles in urban Europe.

There is a body of evidence that ultrafine particles (UFP, those with diameters ≤ 100 nm) might have significant impacts on health. Accordingly, identifying sources of UFP is essential to develop abatement policies. This study focuses on urban Europe, and aims at identifying sources and quantifying their contributions to particle number size distribution (PNSD) using receptor modelling (Positive Matrix Factorization, PMF), and evaluating long-term trends of these source contributions using the non-parametric Theil-Sen's method.

Assessing disturbances in surviving primary forests of Europe.

Primary forests are of paramount importance for biodiversity conservation and the provision of ecosystem services. In Europe, these forests are scarce and threatened by human activities. However, a comprehensive assessment of the magnitude of disturbances in these forests is lacking, due in part to their incomplete mapping.

Geological Net Zero and the need for disaggregated accounting for carbon sinks.

Achieving net zero global emissions of carbon dioxide (CO), with declining emissions of other greenhouse gases, is widely expected to halt global warming. CO emissions will continue to drive warming until fully balanced by active anthropogenic CO removals. For practical reasons, however, many greenhouse gas accounting systems allow some "passive" CO uptake, such as enhanced vegetation growth due to CO fertilisation, to be included as removals in the definition of net anthropogenic emissions.

Use of energy dispersive X-ray fluorescence to authenticate European wines with protected designation of origin. Challenges of a successful control system based on modelling.

Consumers are willing to pay a higher price for food with geographical origin labels such as Protected Designation of Origin and Protected Geographical Indication. In this work, the elemental profile of wine obtained by XRF, combined with multivariate analyses, is used to authenticate 111 Croatian, Italian and Spanish red and white wines, 102 of them from 20 Protected Designations of Origin, reproducing the circumstances faced by control laboratories, using commercially available wines without traceability records. Wines that shared origin clustered together and separated from those of other regions following multivariate statistical tests.

Does DNA extraction affect the specificity of a PCR method claiming the specific detectability of a genome-edited plant?

Under current EU legislation, genetically modified organisms (GMOs) and derived food and feed products must be authorized as GM food, feed, or seed and appropriate detection methods must be made available for use in official controls. A Real-Time PCR method has recently been published by Chhalliyil et al. claiming to be specific for the detection and identification of genome-edited oilseed rape (OSR) lines commercialized in North America.

Chemicals 2.0 and Why We Need to Bypass the Gold Standard in Regulatory Toxicology.

The use of adverse effect data from animals as the gold standard in regulatory toxicology has a long tradition dating back to the 1960s. It has also been increasingly criticised, based on both scientific and animal welfare concerns, and yet, animal studies remain the gold standard in most areas of toxicology to this very day. In the 1980s, when the first generation of non-animal methods were evaluated as alternatives to animal testing, it was logical to compare the 'new' data obtained with historical animal data.

Analyzing sex imbalance in EGA and dbGaP biological databases: Recommendations for better practices.

Precision medicine aims at tailoring treatments to individual patient's characteristics. In this regard, recognizing the significance of sex and gender becomes indispensable for meeting the distinct healthcare needs of diverse populations. To this end, continuing a trend of improving data quality observed since 2014, the European Genome-phenome Archive (EGA) established a policy in 2018 that mandates data providers to declare the sex of donor samples, aiming to enhance data accuracy and prevent imbalance in sex classification.

Evaluation of Two Particle Number (PN) Counters with Different Test Protocols for the Periodic Technical Inspection (PTI) of Gasoline Vehicles.

Thousands of particle number (PN) counters have been introduced to the European market, following the implementation of PN tests during the periodic technical inspection (PTI) of diesel vehicles equipped with particulate filters. Expanding the PN-PTI test to gasoline vehicles may face several challenges due to the different exhaust aerosol characteristics. In this study, two PN-PTI instruments, type-examined for diesel vehicles, measured fifteen petrol passenger cars with different test protocols: low and high idling, with or without additional load, and sharp accelerations.