Putting Science into Standards workshop on standards for organ-on-chip.

A wealth of evidence attests that the organs of developing embryos, particularly the developing brain, are acutely sensitive to chemical perturbations. However, scientists know very little about how exposures to specific endogenous chemicals actually impact human development or children’s ability to learn. And there are almost no data on how the vast majority of the 84,000 chemicals currently listed in the Toxic Substances Control Act (TSCA) Inventory1—including most of the 201 compounds known to be neurotoxic to adults and the 1,000 chemicals shown to be neurotoxic to animals2—may affect developing infants. It is also unclear whether testing with animals always provides accurate insights into human developmental susceptibility. A new line of research based on human stem cells is providing important insights into how chemicals may affect neonatal development. Stem cells are the master cells capable of producing some or all of the 200-plus different types of cells in the human body. In time, some researchers believe stem cells may enable scientists to amass far more data on how exposure to environmental chemicals affects human development, particularly the development of the brain. Now is a “critical time to be talking about stem cell research in the environmental health context,” says Tracey Woodruff, director of the Program on Reproductive Health and the Environment at the University of California, San Francisco (UCSF) Medical School.

This article provides insights into the European Medicines Agency's approach to horizon scanning as a foresight tool to support early identification, analysis and preparedness for emerging trends, technologies and challenges relevant to medicines development and authorization. Emerging topics are identified through a continuous scanning of several sources of information, including key trends identified by leading institutions such as the World Health Organization, the European Commission Joint Research Centre, and the European Innovation Council. This perspective sets out the scope, impact and outputs of horizon scanning within the European medicines regulatory network, which include topic-specific reports, collaborative workshops and webinars, and contributions to regulatory policy, strategic planning, capacity building and research prioritization. It also emphasizes the European medicines regulatory network's commitment to collaboration and knowledge sharing across European and international organizations. Through these efforts, horizon scanning supports regulatory preparedness and resilience of the European medicines regulatory system.

The Safe and Sustainable-by-Design (SSbD) framework by the EC-JRC (European Commission - Joint Research Centre) provides a structured approach to integrate safety and sustainability considerations from the earliest stages of chemical and material innovation. However, applying SSbD principles to advanced materials poses specific challenges due to their complex and diverse physicochemical properties. This work analyzes and maps hazard, exposure, fate and risk assessment methods and tools applicable to Steps 1, 2 and 3 of the EC-JRC SSbD framework, categorizing them across its three tiers to address different stages of product development. The analysis highlights the challenges of adapting conventional testing and modelling approaches to advanced materials, particularly for hazard assessment, and considers the relevance and limitations of tools originally developed for exposure and risk assessment of engineered nanomaterials when applied to broader advanced materials categories. An assessment of operational status, access conditions, and tool formats provides practical insights for researchers and industry stakeholders. The study identifies key methodological gaps and offers recommendations to improve and expand the current tool landscape. By providing a structured mapping of available resources and challenges, this work supports the effective implementation of SSbD principles, promoting the safe and sustainable development of advanced materials.

The GIS-based SafeAirView software for the concentration assessment of radioactive pollutants after an accidental release

The European Union Reference Laboratory for Genetically Modified Food and Feed (EU-RL GMFF), accredited under ISO/IEC 17043, organised a comparative testing (CT) round for National Reference Laboratories (NRLs) nominated under Regulation (EC) No 882/2004, with voluntary participation of other official control laboratories.\nThe test items consisted of rice noodles and commercial soybeans spiked with ground powder of soybean event DP-356043-5 in two different concentrations (Level 1 and 2). Participants were required to perform species identification and test for the presence of any GM event in the two test items. Any event detected then had to be quantified. Participants could report the results in mass/mass % or copy/copy % and the EU-RL GMFF calculated the robust means (R) for Level 1 and 2 test items accordingly. The target standard deviation for CT was fixed by the Advisory Board for Comparative Testing at 0.2 for the event, based on the experience of previous CT rounds. The robust means and target standard deviation were used to derive z-scores for the participants’ results. \nEighty-eight laboratories from 42 countries registered for this CT round, of which 85 laboratories from 41 countries returned at least qualitative test results. \nWhen performing species identification, almost all laboratories correctly identified soybean and rice in both test items, and a few laboratories also detected maize and/or oilseed rape. In total 71 laboratories reported the presence of GM material in the test items, but 14 laboratories failed in this task. All of the 71 laboratories, except eight, correctly identified soybean event DP-356043-5 in the test items.\nResults of the quantitative evaluation of the GM content were satisfactory for both measurement units, with only two NRLs appointed under Regulation (EC) No 1981/2006 (one measuring in m/m % and one in cp/cp %) obtaining unsatisfactory z-scores (|z| ≥ 2.0) for both test items. \nDespite the overall satisfactory outcome of this CT round, only 58 % of participants provided information on measurement uncertainty in a complete and consistent manner, and further improvement in this crucial area is needed.

Within the framework of the ALOS Kyoto & Carbon Initiative, the European Commission Joint Research Centre (JRC) is in charge for the generation of a 50 m pixel spacing L-band SAR mosaic over the African continent. The mosaic is generated from full resolution (20 m), dual polarisation (HH+HV) ALOS PALSAR data, acquired from June through October 2007. The mosaic is scheduled for release in the autumn of 2009, and will be made available free of change to scientific users worldwide through the JRC and JAXA. This paper provides a brief overview of the K&C Initiative, and a short description of the procedures employed by the JRC for the Africa mosaic generation.

From a safeguards perspective, gamma-ray imaging has the potential to reduce manpower and cost for effectively locating and monitoring special nuclear material. The purpose of this project was to investigate the performance of pinhole and coded aperture gamma-ray imaging systems at Oak Ridge National Laboratory (ORNL). With the aid of the European Commission Joint Research Centre (JRC), radiometric data will be combined with scans from a three-dimensional design information verification (3D-DIV) system. Measurements were performed at the ORNL Safeguards Laboratory using sources that model holdup in radiological facilities. They showed that for situations with moderate amounts of solid or dense U sources, the coded aperture was able to predict source location and geometry within ~7% of actual values while the pinhole gave a broad representation of source distributions

In March 2005, U.S. authorities informed the European Commission of the inadvertent release of unauthorized maize GM event Bt10 in their market and subsequently the grain channel. In the United States measures were taken to eliminate Bt10 from seed and grain supplies; in the European Union an embargo for maize gluten and brewer's grain import was implemented unless certified of Bt10 absence with a Bt10-specific PCR detection method. With the aim of assessing the validity of the Bt10 detection method, an in-depth analysis of the molecular organization of the genetic modification of this event was carried out by both the company Syngenta, who produced the event, and the European Commission Joint Research Centre, who validated the detection method. Using a variety of molecular analytical tools, both organizations found the genetic modification of event Bt10 to be very complex in structure, with rearrangements, inversions, and multiple copies of the structural elements (cry1Ab, pat, and the amp gene), interspersed with small genomic maize fragments. Southern blot analyses demonstrated that all Bt10 elements were found tightly linked on one large fragment, including the region that would generate the event-specific PCR amplicon of the Bt10 detection method. This study proposes a hypothetical map of the insert of event Bt10 and concludes that the validated detection method for event Bt10 is fit for its purpose.

The flexicurity concept created in the Netherlands and Denmark in the early 1990s has become the main stepping-stone in improving the performance of labour markets across the European Union Member States. The European Commission has therefore taken a leading role on broader flexicurity concept development and creation of the data analysis methodology. However, the analysis proposed by the European Commission Joint Research Centre on flexicurity indicators in 2010 only partly includes business start-ups as a flexible form of employment. This research starts the discussion on whether additional indicators should be integrated in the flexicurity analysis, because of the rising need for employment security through entrepreneurial activity.

Over the last years the awareness about jamming and spoofing risks has been increasing, particularly in the timing community since they may cause the disruption of critical services and infrastructures in the Telecommunication, Energy and Finance sectors that rely on GNSS timing to operate. In order to overcome these hazards, the European GNSS Agency (GSA) has funded the development of timing receivers for professional applications, with the aim to address specifically the above vulnerabilities, improve the receiver robustness and the accuracy and reliability of time transfer. In this context the GIANO (Galileo-based timing Receiver for Critical infrastructures robustness) project consortium, coordinated by Thales Alenia Space (TAS) Italy and with the support of Deimos Engenharia S.A. (Portugal), the Space Research Centre PAS in Poznan (Poland), Piktime System SP. Zoo (Poland) and Business Integration Partner S.p.A. (Italy), has been awarded a contract in the framework of the GSA’s “Fundamental Elements” program to develop a timing receiver for critical infrastructure applications. Besides the implementation of some interference and spoofing detection and mitigation techniques, GIANO receiver makes use of Galileo’s authentication service OSNMA (Open Service Navigation Message Authentication), which can be employed as an added defense against some types of spoofing. OSNMA exploits TESLA (Time Efficient Stream Loss-tolerant Authentication) scheme, which is a protocol based on the transmission of message authentication codes generated with a key that is broadcast with some delay. The receiver authenticates the satellite messages through a Digital Signature algorithm and a public key known by the receivers, which also validates the root key of the TESLA chain, and through MACs (Message Authentication Codes) which are used to authenticate specific fields of the Navigation Message. The receiver will also support public key renewals over the air. In this paper, the OSNMA implementation within GIANO receiver, including the cryptographic operations required is presented. The GIANO OSNMA capability will be extensively tested and validated with the support of European Commission Joint Research Centre (Ispra, Italy).

A Transformer-based method to reduce cloud shadow interference in automatic lake water surface extraction from Sentinel-2 imagery

Local governments worldwide face challenges to meet the Paris Climate Agreement 2015 and its targets amid the high CO2 emissions. Municipalities should play a major role in addressing climate actions and transform cities to more sustainable energy resources to attain SDGs. The European Union initiated a major project ‘Cleaner Energy Saving Mediterranean Cities’ (CES-MED) from 2011 to 2018, which is under the European Neighbourhood and Partnership Instrument (ENPI) to support South Mediterranean countries in developing Sustainable Energy and Climate Action Plans—SECAP. This chapter presents strategic action plans to support and strengthen the capacity of local authorities to embrace and implement sustainable development and clean energy policies in line with existing national regulatory and legislative frameworks yet to understand the energy consumption in all sectors that utilize energy in the city, map energy consumption and CO2 emissions over 1 year, develop priority planned actions and establish climate actions. This chapter also highlights the assessment that was conducted on eight sectors such as transport, residential, tertiary and government buildings, agriculture, industry, waste, wastewater and tourism in two cities (Hurghada and Luxor) in Egypt. The assessment is based on the calculation of energy use and GHG emission according to the methodology of the European Commission Joint Research Centre (EC-JRC). The planned action and climate actions comprise of seven priority actions for the city of Hurghada and five priority actions for the city of Luxor including as follows: (1) transport, urban sustainable mobility master plan; (2) tourism, sustainable green boats; (3) tourism, green and sustainable hotels and resorts; (4) sustainable approach for governorate buildings; (5) sustainable approach for residential building; (6) solar energy development; and (7) green city awareness unit. However, in this paper, the first three priority actions are presented. Results in the city of Luxor (2015) indicate that total energy consumption and the corresponding global GHG emissions are estimated to be 4937 GWh/year and 1797 ktCO2eq/year, whereas these are 3338 GWh/year and 1338 ktCO2eq/year in Hurghada.

Effects on biodiversity in semi-natural pastures of giving the grazing animals access to additional nutrient sources: a systematic review (European Commission Joint Research Centre).

BackgroundWith hundreds of registries across Europe, rare diseases (RDs) suffer from fragmented knowledge, expertise, and research. A joint initiative of the European Commission Joint Research Center and its European Platform on Rare Disease Registration (EU RD Platform), the European Reference Networks (ERNs), and the European Joint Programme on Rare Diseases (EJP RD) was launched in 2020. The purpose was to extend the set of common data elements (CDEs) for RD registration by defining domain-specific CDEs (DCDEs).ObjectiveThis study aims to introduce and assess the feasibility of the concept of a joint initiative that unites the efforts of the European Platform on Rare Disease Registration Platform, ERNs, and European Joint Programme on Rare Diseases toward extending RD CDEs, aiming to improve the semantic interoperability of RD registries and enhance the quality of RD research.MethodsA joint conference was conducted in December 2020. All 24 ERNs were invited. Before the conference, a survey was communicated to all ERNs, proposing 18 medical domains and requesting them to identify highly relevant choices. After the conference, a 3-phase plan for defining and modeling DCDEs was drafted. Expected outcomes included harmonized lists of DCDEs.ResultsAll ERNs attended the conference. The survey results indicated that genetic, congenital, pediatric, and cancer were the most overlapping domains. Accordingly, the proposed list was reorganized into 10 domain groups and recommunicated to all ERNs, aiming at a smaller number of domains.ConclusionsThe approach described for defining DCDEs appears to be feasible. However, it remains dynamic and should be repeated regularly based on arising research needs.

Socio‐Economic Benefits From the Use of Earth Observation; Ispra, Italy, 11–13 July 2011 Many large space‐or ground‐based Earth observation systems, such as Global Monitoring for Environment and Security (GMES) and Landsat, are justified by citing their benefits to scientific knowledge and their impacts on government decisions about environmental issues. These justifications attempt to quantify the lives saved, losses avoided, or economic benefits gained. Each justification is made on an ad hoc basis, and the approach used in one case rarely applies to another. In July 2011 a workshop was held at the European Commission Joint Research Centre in Italy to consider whether broadly applicable methodologies could be developed that could be consistently used for assessing the value of large‐scale observation and information systems.