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Background: Amyotrophic lateral sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no significant improvements in therapeutic options for ALS patients in recent years. Currently, there is no cure for ALS, and the only approved treatment in Europe is riluzole, which has been shown to slow the disease progression and prolong survival by approximately 3 months. Recently, tauroursodeoxycholic acid (TUDCA) has emerged as a promising and effective treatment for neurodegenerative diseases due to its neuroprotective activities. Methods: The ongoing TUDCA-ALS study is a double-blinded, parallel arms, placebo-controlled, randomized multicenter phase III trial with the aim to assess the efficacy and safety of TUDCA as add-on therapy to riluzole in patients with ALS. The primary outcome measure is the treatment response defined as a minimum of 20% improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) slope during the randomized treatment period (18 months) compared to the lead-in period (3 months). Randomization will be stratified by country. Primary analysis will be conducted based on the intention-to-treat principle through an unadjusted logistic regression model. Patient recruitment commenced on February 22, 2019, and was closed on December 23, 2021. The database will be locked in September 2023. Discussion: This paper provides a comprehensive description of the statistical analysis plan in order to ensure the reproducibility of the analysis and avoid selective reporting of outcomes and data-driven analysis. Sensitivity analyses have been included in the protocol to assess the impact of intercurrent events related to the coronavirus disease 2019. By focusing on clinically meaningful and robust outcomes, this trial aims to determine whether TUDCA can be effective in slowing the disease progression in patients with ALS. Trial registration: ClinicalTrials.gov NCT03800524. Registered on January 11, 2019. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic in just a few weeks has turned the whole planet upside down: from an open accessible world we have transformed into a closed fragmented particular world separated by hard transient borders. For several months, airlines in Europe suspended almost all their operations and the airports were closed for the commercial aviation. The COVID-19 crisis has caused a collapse in the air traffic and had a catastrophic impact of the airline industry and the aviation value chain. The coronavirus pandemic exposed many weaknesses across the European aviation system for which the relevant institutions did not have a quick and efficient fix. And while we are slowly and conditionally regaining the freedom to travel within the European countries and across continents, the future of air transport is being jeopardized by this global health crisis, both in term of short-term safety and economic impact and its long-term values and responsibilities. In the field of civil aviation safety, the emphasis has shifted from the security measures against acts of unlawful interference, to measures and activities to protect the human health. All relevant international civil aviation organizations began working closely together with the most important international institutions for control of infectious diseases, in the creation of special protocols for protection against COVID-19 in air traffic. Health safety is now an intrinsic element of the aviation safety. It is very clear that air travel will never be the same again and that the air transport industry should contribute to reinventing the travel experience for the future. Because of all this, the aim of this paper is to identify the most significant safety challenges facing the European air transport system in conditions of global health crisis. At the same time, the paper is giving some useful thoughts and recommendations for sustainable implementation of appropriate and efficient safety measures by the entities in the international and domestic aviation industry. [ABSTRACT FROM AUTHOR]

This paper presents an innovative global navigation satellite system (GNSS) fault detection and exclusion approach for the adoption of satellite localization in the rail sector. Current global integrity monitoring systems cannot guarantee the safety level needed for such applications as train control where tolerable hazard rate in the order of 10−9/h is required. A new method, named two tiers, enabling to integrate local augmentation systems and global augmentation infrastructures, is presented. It is based on the comparison of single differences residuals among satellites for detecting signal in space (SIS) faults and double difference residuals among local augmentation stations and satellite-based augmentation systems ranging and integrity monitoring stations for detecting reference stations faults. GPS SIS faults described in literature and real GNSS raw data recorded on a train are taken into account. This study reports the performance analysis for the two-tiers approach carried out during relevant European projects. A test-bed architecture has been developed through the implementation of the algorithm in real time on a local augmentation operational center. Relevant performances have been tested on a rail track for validating the algorithm in real operative conditions. Significant results of the analysis are reported for SIS integrity assessment only. [ABSTRACT FROM AUTHOR]

This paper outlines a means to manage electrical competence in an international oil company (IOC), and it begins to explore the connections that may be possible to the industry in general and a possible role for the Petroleum and Chemical Industry Committee (PCIC) in this process. A key objective is to allow new employees in the electrical discipline to add value to the business as quickly and effectively as possible. This sometimes involves the acquisition of new knowledge and behaviors. Some resources and programs are available in the open market, but these are usually not well matched to the specific needs of the industries covered by the oil, gas, and chemical sector, i.e., the focus is more often on utility companies. By sharing the needs of this IOC and the initial response from PCIC Europe, it is hoped to stimulate further thinking and possible alignment on this important subject. [ABSTRACT FROM AUTHOR]

Objective: Metal Road Safety Barriers (MRSB) are one of the devices implemented in roadsides to mitigate the consequences of run-off crashes. In Europe, they have to meet the requirements of the European Standard EN-1317-2. This article analyzes a set of run-off crashes against MRSB, for which an in-depth investigation has been performed, comparing them with the standard tests. It has been observed that in many of these real crashes, the barriers have not worked properly in spite of having passed these standard tests. This paper demonstrates which variables may be responsible for this, with the objective of helping to improve the current test standard through the analysis of new test variables., Methods: Multidimensional Scaling, a dimension reduction multivariate statistical technique, has been used to better understand how real crashes compare to standard tests, using several impact variables at the same time. Then, a statistical analysis has been developed to show the influence of the "Relative orientation impact angle" on the performance of the MRSB., Results: Most of the real crashes analyzed are close to "TB11" and "TB32" standard tests. In many of these real crashes, the "Relative orientation impact angle" is very different from the "Impact angle", and in these situations, the vehicle is not safely redirected to the road concerning the so-called "Exit-Box"., Conclusions: MRSB are not working properly in some situations that are not far from the standard tests. To handle this, it could be interesting to include the "Relative orientation impact angle" as a control variable in new versions of the EN-1317-2 tests to guarantee the behavior of the MRSB. These results can help to adapt some test variables from the EN-1317-2 to what is happening in crashes., Competing Interests: The authors have declared that no competing interests exist.

Autonomous Vehicles (AV) technology is emerging. Field tests on public roads have been on going in several states in the US as well as in Europe and Asia. During the US public road tests, crashes with AV involved happened, which becomes a concern to the public. Most previous studies on AV safety relied heavily on assessing drivers’ performance and behaviors in a simulation environment and developing automated driving system performance in a closed field environment. However, contributing factors and the mechanism of AV-related crashes have not been comprehensively and quantitatively investigated due to the lack of field AV crash data. By harnessing California’s Report of Traffic Collision Involving an Autonomous Vehicle Database, which includes the AV crash data from 2014 to 2018, this paper investigates by far the most current and complete AV crash database in the US using statistical modeling approaches that involve both ordinal logistic regression and CART classification tree. The quantitative analysis based on ordinal logistic regression and CART models has successfully explored the mechanism of AV-related crash, via both perspectives of crash severity and collision types. Particularly, the CART model reveals and visualize the hierarchical structure of the AV crash mechanism with knowledge of how these traffic, roadway, and environmental contributing factors can lead to crashes of various serveries and collision types. Statistical analysis results indicate that crash severity significantly increases if the AV is responsible for the crash. The highway is identified as the location where severe injuries are likely to happen. AV collision types are affected by whether the vehicle is on automated driving mode, whether the crashes involve pedestrians/cyclists, as well as the roadway environment. The method used in this research provides a proven approach to statistically analyze and understand AV safety issues. And this benefit is potential be even enhanced with an increasing sample size of AV-related crashes records in the future. The comprehensive knowledge obtained ultimately facilitates assessing and improving safety performance of automated vehicles. [ABSTRACT FROM AUTHOR]

Background: Physical inactivity is a major public health concern, exacerbated in countries with a (sub)tropical climate. The built environment can facilitate physical activity; however, current evidence is mainly from North American and European countries with activity-friendly climate conditions. This study explored associations between built environment features and physical activity in global tropical or subtropical dry or desert climate regions. Methods: A systematic review of four major databases (Web of Science, Scopus, PubMed, and SportDISCUS) was performed. To be included, studies had to investigate associations between perceived or objective built environment characteristics and adult's physical activity and had to be conducted in a location with (sub)tropical climate. Each investigated association was reported as one case and results were synthesized based upon perceived and objectively assessed environment characteristics as well as Western and non-Western countries. Study quality was evaluated using a tool designed for assessing studies on built environment and physical activity. Results: Eighty-four articles from 50 studies in 13 countries with a total of 2546 built environment-physical activity associations were included. Design (connectivity, walking/cycling infrastructure), desirability (aesthetics, safety), and destination accessibility were the built environment characteristics most frequently associated with physical activity across the domains active transport, recreational physical activity, total walking and cycling, and moderate-to-vigorous physical activity, particularly if multiple attributes were present at the same time. Very few studies assessed built environment attributes specifically relevant to physical activity in (sub)tropical climates. Most studies were conducted in Western countries, with results being largely comparable with non-Western countries. Findings were largely generalizable across gender and age groups. Results from natural experiments indicated that relocating to an activity-friendly neighborhood impacted sub-groups differently. Conclusions: Built environment attributes, including destination accessibility, connectivity, walking and cycling infrastructure, safety, and aesthetics, are positively associated with physical activity in locations with (sub)tropical climate. However, few studies focus on built environment attributes specifically relevant in a hot climate, such as shade or indoor recreation options. Further, there is limited evidence from non-Western countries, where most of the urban population lives in (sub)tropical climates. Policy makers should focus on implementing activity-friendly environment attributes to create sustainable and climate-resilient cities. [ABSTRACT FROM AUTHOR]

Air transport is considered to be the safest mode of mass transportation. Air traffic management (ATM) systems constitute one of the fundamental pillars that contribute to these high levels of safety. In this paper we wish to answer two questions: (i) What is the underlying safety level of ATM systems in Europe? and (ii) What is the dispersion, that is, how far does each ATM service provider deviate from this underlying safety level? To do this, we develop four hierarchical Bayesian inference models that allow us to infer and predict the common rate of occurrence of SMIs, as well as the specific rates of occurrence for each air navigation service provider (ANSP). This study shows the usefulness of hierarchical structures when it comes to obtaining parameters that enable risk to be quantified effectively. The models developed have been found to be useful in explaining and predicting the safety performance of 29 European ATM systems with common regulations and work procedures, but with different circumstances and numbers of aircraft, each managing traffic of differing complexity. [ABSTRACT FROM AUTHOR]

This paper concerns the procedure and the scientific approach to obtain market authorization for a microorganism to be recognized as a novel food with a health claim. Microorganisms that have not been traditionally used during food production in Europe prior to 1997 are considered as novel foods, which should undergo an in-depth characterization and safety assessment before being authorized on the European market. If a novel food bacterium is claimed to provide a beneficial effect on health, these claims must also be investigated before they can be authorized. Some requirements to obtain novel food certification are shared with those required to obtain a health claim. Although regulation exists that deals with these issues for foods in general, bacteria in food raise a specific set of questions that are only minimally addressed in official documentation. We propose a framework and suggest a list of criteria that should be assessed to obtain marketing authorization and health claim for a bacterium in accordance with European health policy. [ABSTRACT FROM AUTHOR]

This paper reviews European trends regarding young drivers' accident risk and the effects of countermeasures. Young driver risk differs between countries, and has improved in the last decade, probably as a result of general improvements in road safety levels. Young male drivers' relative risk is rising, indicating that current policies are less effective for males than for females. Further research is needed to understand the causes of this development. In Europe, most countries are moving toward multiphase licensing systems, including elements like accompanied driving, protective measures, and probation periods. European evaluation studies show mixed results regarding these elements, pointing to a need for more research into the effective components.

The paper aims to present the shared space concept and different methods of application in European cities. There are also presented practical lessons learned form shared space experience to be applied in Romanian cities and also next steps for learning and advancing shared space. [ABSTRACT FROM AUTHOR]

This paper presents the initial results from a study into the interaction between safety culture and degraded modes of operation in European Air Traffic Management (ATM). Degraded modes occur when operators struggle to maintain levels of service eventhough key elements of their infrastructure have failed. Safety culture can be simply described as ‘the way safety is done around here’ – emphasizing that it is concerned with the realities of safety, and not necessarily what people say should be done. Although safety culture therefore deals necessarily with attitudes, beliefs and even feelings – so-called ‘soft’ phenomena – it does not mean that these are any less important than more objective and visible safety management artifacts such as standards and procedures, and so on. Poor safety culture is often linked to the causes of major accidents and incidents. Recent initiatives in ATM, including the European Safety Programme and its precursor, the Strategic Safety Action Plan, have also recognized that degraded modes of operation played a significant role in previous adverse events. Operators often reveal a high degree of tolerance for degraded infrastructures. There is a ‘can do’ attitude, whereby staff struggle to maintain operations when it might be more prudent to reduce the level of service or even close airspace in order to maintain levels of safety. The high level objectives of this project are: (1) to identify safety cultural aspects that influence tolerance to degraded modes and (2) to identify ‘best practices’ that Air Navigation Service Providers can apply to deal with degraded mode of operations. [ABSTRACT FROM AUTHOR]

We investigated the association between perceived neighbourhood characteristics and falls in community-dwelling adults, using data from Wave 5 and 6 of the Survey of Health, Ageing and Retirement in Europe (SHARE). We included 25,467 participants aged 50 to 103 years (mean age 66.2 ± 9.6, 58.5% women), from fourteen European countries (Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Israel, Italy, Luxembourg, Slovenia, Spain, Sweden, Switzerland). At baseline, we recorded individual-level factors (socio-demographic, socio-economic and clinical factors), contextual-level factors (country, urban versus rural area, European region) and perceived neighbourhood characteristics (vandalism or crime, cleanliness, feeling part of neighbourhood, helpful neighbours, accessibility to services) for each participant. We recorded falls in the six months prior to the baseline and 2-year follow-up interviews. The associations between neighbourhood characteristics and falls were analysed by binary logistic regression models; odds ratios (95% confidence intervals) were calculated. Participants reporting-versus not reporting-vandalism or crime had an increased falls risk of 1.16 (1.02–1.31) at follow-up, after full adjustment; lack of cleanliness, feeling part of the neighbourhood, perceiving neighbours as helpful and difficult accessibility to services were not associated with falls. Vandalism or crime was consistently associated with increased falls risks in women, adults without functional impairment and urban areas residents. In conclusion, adverse neighbourhood environments may account for inequality in falls risk among middle-aged and older adults and could be added to fall risk stratification tools. [ABSTRACT FROM AUTHOR]

Inattentiveness of road users on approach to passive railway crossings represents a major threat to level crossing safety. An auxiliary strobe light system installed on trains in addition to existing headlights may help address this issue by providing an ergonomic way of attracting human attention to the level crossing and to the train. The objective of this paper was to investigate the ergonomics and safety potential of auxiliary strobe light systems. A system was implemented on a real railway vehicle and in the virtual environment of a driving simulator. Acceptance of the system, including its usefulness and perceived benefits and drawbacks, as well as its objective effectiveness, were evaluated using questionnaires, behavioural measures, and eye tracking. The safety potential of the system was evaluated with respect to fatal level crossing accidents. The auxiliary strobe lights were preferred over normal lights and were rated as useful, reducing driving speeds, increasing visual scanning at level crossings, and thus aiding detection of a train. The system has the potential to prevent 6-30% of level crossing accidents in Europe. The results suggest that it might be worthwhile to test auxiliary strobe lights in a larger scale real-world experiment. Especially on railway lines with a high number of passive level crossings, this system can be expected to increase safety by supporting timely detection by road users and preventing accidents caused by inattentiveness. [ABSTRACT FROM AUTHOR]

Edible jellyfish are a traditional Southeast Asian food, usually prepared as a rehydrated product using a salt and alum mixture, whereas they are uncommon in Western Countries and considered as a novel food in Europe. Here, a recently developed, new approach for jellyfish processing and stabilization with calcium salt brining was upgraded by modifying the pre-treatment step of freshly caught jellyfish and successfully applied to several edible species. Treated jellyfish obtained by the application of the optimized version of this method respected both quality and safety parameters set by EU law, including no pathogenic microorganisms, absence or negligible levels of histamine and of total volatile basic nitrogen, no heavy metals; and the total bacterial, yeast, and mold counts were either negligible or undetectable. Jellyfish treated by the presented method exhibited unique protein content, amino acid and fatty acid profiles, antioxidant activity, and texture. The optimized method, initially set up on Rhiszostoma pulmo, was also successfully applied to other edible jellyfish species (such as Cotylorhiza tuberculata, Phyllorhiza punctata, and Rhopilema nomadica) present in the Mediterranean Sea. This study discloses an innovative process for the preparation of jellyfish-based food products for potential future distribution in Europe. [ABSTRACT FROM AUTHOR]

Favoring innovation by making timely medical technology available to people and by securing patients' safety is a challenge. The new European Medical Device Regulation (MDR) will have a central implication in the development of new devices and could affect their innovation and availability, as well as discourage investment in research within Europe. Start-ups and small companies might not be able to cope with the increasing complexity and the required changes of perspective. Health-care institutions are facing an increasing availability of complex technologies, while data on their clinical efficacy and cost-effectiveness are rarely provided. A partnership/collaboration between health-care institutions, academia, and private industries will enhance their own specific interests with the common goal of improving overall health and quality of life. The complexity of the subject combined with the variety of specialists and stakeholders involved requires the implementation, in hospital centers of clinical excellence, of units dedicated to the whole path of the medical device innovation. Stakeholders should quickly provide adequate measures to facilitate the complex medical device innovation path under the more stringent MDR aimed to increase safety and quality of care. [ABSTRACT FROM AUTHOR]

Actinic keratosis (AK) is a chronic skin condition that may progress to cutaneous squamous cell carcinoma. We conducted a systematic review of efficacy and safety for key treatments for AK of the face and scalp, including the novel 5-day tirbanibulin 1% ointment. MEDLINE, PubMed, Embase, Cochrane Library, clinical trial registries and regulatory body websites were searched. The review included 46 studies, of which 35 studies included interventions commonly used in Europe and were sufficiently homogenous to inform a Bayesian network meta-analysis of complete clearance against topical placebo or vehicle. The network meta-analysis revealed the following odds ratios and 95% credible intervals: cryosurgery 13.4 (6.2–30.3); diclofenac 3% 2.9 (1.9–4.3); fluorouracil 0.5% + salicylic acid 7.6 (4.6–13.5); fluorouracil 4% 30.3 (9.1–144.7); fluorouracil 5% 35.0 (10.2–164.4); imiquimod 3.75% 8.5 (3.5–22.4); imiquimod 5% 17.9 (9.1–36.6); ingenol mebutate 0.015% 12.5 (8.1–19.9); photodynamic therapy with aminolevulinic acid 24.1 (10.9–52.8); photodynamic therapy with methyl aminolevulinate 11.7 (6.0–21.9); tirbanibulin 1% 11.1 (6.2–20.9). Four sensitivity analyses, from studies assessing efficacy after one treatment cycle only, for ≤25 cm2 treatment area, after 8 weeks post-treatment, and with single placebo/vehicle node confirmed the findings from the base case. Safety outcomes were assessed qualitatively. These results suggest that tirbanibulin 1% offers a novel treatment for AK, with a single short treatment period, favourable safety profile and efficacy, in line with existing topical treatments available in Europe. [ABSTRACT FROM AUTHOR]

Abstract: Background/objectives: Between 1982 and 2011, 84 clinical studies were performed by the manufacturers of Influvac®, including the annual update studies required for licensing in Europe. This paper presents data from a 30-year evaluation of clinical experience with Influvac®. Subjects and methods: In all, 8776 subjects were vaccinated with Influvac®, including healthy adults, healthy elderly subjects, adult and elderly at-risk subjects, and healthy and at-risk children. All subjects received the trivalent inactivated subunit influenza vaccine Influvac® (Abbott, Weesp, The Netherlands). Subjects recorded solicited local and systemic reactions for 3–7days after vaccination. Inconvenience was scored in some studies. Unsolicited reports of adverse events were collected up to 21days after vaccination. Haemagglutination inhibition (HI) antibody titres were determined before and up to 45weeks after vaccination with Influvac®. The immunogenicity of Influvac® was assessed using the criteria of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Post marketing surveillance data were also analyzed. Results: Treatment-emergent adverse events up to 21days after vaccination were reported by 583 of 4746 subjects (12.3%), most commonly headache. Overall, 2318 of 6825 subjects (34.0%) recorded local reactions (most commonly tenderness and pain on slightest pressure) and 1229 of 6825 subjects (18.2%) recorded systemic reactions (most commonly headache and fatigue). All local and systemic reactions were mild or moderate and resolved in 1–2days. Most subjects in each population group reported inconvenience as none-to-mild. Post marketing surveillance data collected from 1982 to 2012 indicated an overall reporting rate of 24.5 events/million doses. The age-specific CHMP serological criteria for immunogenicity were generally met in all the adult and elderly populations and the HI antibody titres and derived serological parameters in children were similar to those in adults. The CHMP requirement for immunogenicity for annual re-licensing for both healthy adults and elderly subjects was consistently met over the 30-year period. One study in elderly subjects demonstrated that HI antibody titres were maintained at relatively high levels for at least 6months, providing coverage throughout the influenza season, but by 1year after vaccination antibody titres had declined to low enough levels to necessitate revaccination. Conclusions: This review of the 30-year clinical experience with Influvac® found that the overall benefit-to-risk ratio is positive for all age groups from 6months upwards. The currently available evidence from the many clinical trials that have been performed confirms that Influvac® remains an effective and safe vaccine for preventing seasonal influenza. [Copyright &y& Elsevier]

Abstract: In order to investigate the accidental behavior of the helium cooled test blanket module and its auxiliary systems, a particular sequence has been selected for the deterministic analyses in the frame of the EFDA licensing task for ITER. This sequence starts from an ex-vessel loss of coolant with simultaneous assumed failure of the plasma shutdown system. This paper presents the study of this sequence with the use of various assumptions and code-dependent modeling (RELAP5, MELCOR and ANSYS). Two different variants of the sequence are analyzed depending on the assumption of the failure of water-cooled component of ITER. The resulting transients show the effect of the exposure of the Be pebble beds on air and on a mixture of air and steam. [Copyright &y& Elsevier]

Abstract: The Advisory Council for Aeronautics Research in Europe (ACARE) predicts that European air traffic may nearly triple by 2020. The growth in air traffic is already an increasing problem with capacity at some airports becoming limited due to congestion. This could be alleviated by providing additional passenger capacity at hubs through the introduction of rotorcraft using new IFR procedures and operating simultaneously but independently of the fixed-wing traffic. These Simultaneous Non-Interfering Operations (SNIOps) will be enabled by a ‘reconfiguration’ of the airspace, taking advantage of new navigational and air traffic management systems. SNIOp''s raise critical safety questions for rotorcraft wake vortex encounters (WVE''s) and will require consideration of the longitudinal and lateral aircraft separation and the locations of the rotorcraft FATO''s (Final Approach and Take-Off areas). This paper presents analysis from work carried out as part of the Framework 6 project ‘OPTIMAL’ including the development of predictive methodology and analysis for rotorcraft WVE''s, using a severity rating scale. In particular, scenarios are considered where the rotorcraft is following precision glideslopes of up to 12° in both good and degraded visual conditions. Handling qualities criteria have already been found to be well suited to investigating severity of an encounter. Within this framework, draft boundaries are proposed for assessing the severity of an encounter. Furthermore, the results have shown a pilot may be able to recover from an encounter, but the question of whether the required navigational precision would be compromised and a go-around required is also addressed. [Copyright &y& Elsevier]

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the new European chemical legislation which aims to assess risk or safety of tens of thousands of chemicals to improve the protection of human health and the environment. The chemical safety assessment process is of an iterative nature. First, an initial, worst-case assessment is conducted after which refinements are made until no risk has been estimated or the risk is adequately controlled. Wasting time and resources on additional testing and implementing risk management measures with low effect on risk conclusions should be avoided as much as possible. This paper demonstrates the usefulness of an intelligent data collection strategy based on a sensitivity (and uncertainty) analysis on the risk assessment model EUSES to identify and order the most important “within-EU-TGD-reducible” input parameters influencing the local and regional risk characterisation ratios. The ordering can be adjusted for the costs involved in additional testing (e.g. ecotoxicity, physico-chemical properties, emission estimates, etc.). The risk refinement tool therefore reduces the resources needed to obtain a realistic risk estimate (both less conservative and less uncertain) as efficient as possible. [Copyright &y& Elsevier]

Under the new REACH system, companies importing, producing and marketing chemical substances will be obliged to register the single substances and to carry out a safety assessment for all identified uses during the life cycle of the substance. This duty will apply to about 10,000 existing substances in the EU market exceeding an annual production or import volume of 10 t per company. If the substance is already known to be dangerous or turns out to be dangerous1 during the hazard assessment, the registrant is obliged to carry out an exposure assessment and a risk characterisation for all identified uses. The goal of the safety assessment is to define the conditions of use that allow for adequate control of risk with regard to health and safety at the work place, consumer safety and protection of the environment. Once the registrant has established and documented these conditions in the Chemicals Safety Report (CSR), that information is to be communicated down the supply chain by means of the Extended Safety Data Sheet (eSDS). The ultimate aim of the new legislation is to establish duties and mechanisms that systematically prevent or limit exposure to dangerous industrial chemicals. The current paper explains this concept with regard to environmental exposure and highlights the challenges and possible solutions.Journal of Exposure Science and Environmental Epidemiology (2007) 17, S7–S15; doi:10.1038/sj.jes.7500602; published online 14 November 2007 [ABSTRACT FROM AUTHOR]

Under current European hygiene legislation, food businesses are obliged to develop and implement food safety management systems (FSMS) including prerequisite programme (PRP) activities and hazard analysis and critical control point principles. This requirement is especially challenging for small food retail establishments, where a lack of expertise and other resources may limit the development and implementation of effective FSMS. In this opinion, a simplified approach to food safety management is developed and presented based on a fundamental understanding of processing stages (flow diagram) and the activities contributing to increased occurrence of the hazards (biological, chemical (including allergens) or physical) that may occur. The need to understand and apply hazard or risk ranking within the hazard analysis is removed and control is achieved using PRP activities as recently described in the European Commission Notice 2016/C278, but with the addition of a PRP activity covering 'product information and customer awareness'. Where required, critical limits, monitoring and record keeping are also included. Examples of the simplified approach are presented for five types of retail establishments: butcher, grocery, bakery, fish and ice cream shop. [ABSTRACT FROM AUTHOR]

In this article, we examine the relationship between safety culture and national culture, and the implications of this relationship for international safety culture assessments. Focussing on Hofstede's uncertainty avoidance ( UA) index, a survey study of 13,616 Air Traffic Management employees in 21 European countries found a negative association between safety culture and national norm data for UA. This is theorized to reflect the influence of national tendencies for UA upon attitudes and practices for managing safety (e.g., anxiety on risk; reliance on protocols; concerns over reporting incidents; openness to different perspectives). The relationship between UA and safety culture is likely to have implications for international safety culture assessments. Specifically, benchmarking exercises will consistently indicate safety management within organizations in high UA countries to be poorer than low UA countries due to the influence of national culture upon safety practices, which may limit opportunities for identifying and sharing best practice. We propose the use of safety culture against international group norms ( SIGN) scores to statistically adjust for the influence of UA upon safety culture data, and to support the identification of safety practices effective and particular to low or high UA cultures. Practitioner points National cultural tendencies for uncertainty avoidance (UA) are negatively associated with safety culture., This indicates that employee safety-related attitudes and practices may be influenced by national culture, and thus factors outside the direct control of organizational management., International safety culture assessments should attempt to determine the influence of national culture upon safety culture in order that benchmarking exercises compare aspects of safety management and not national culture., Safety culture against international group norms (SIGN) scores provide a potential way to do this, and can facilitate the identification of best practice within countries operating in a low or high UA cultural cluster. [ABSTRACT FROM AUTHOR]

The article presents views of the author regarding digital advancements being a threat to journalism. Topics discussed include business and private lives interaction remaining dormant in digital mind of service providers, communications of journalists being susceptible to authorities interrogation and investigatory powers bill for security and privacy being implemented in Europe and Great Britain.

Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate. [ABSTRACT FROM AUTHOR]

L-Threonine, technically pure, is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of the European Food Safety Authority (EFSA) issued an opinion on the safety and efficacy of the product, in which it could not conclude on the safety of this additive for target animals, consumer, user and the environment, due to insufficient characterisation of the genetic modification. The European Commission asked EFSA to deliver an opinion on the safety of L-Threonine, technically pure, as a nutritional additive for all animal species based on additional data submitted by the applicant. Neither the production strain nor its recombinant genes are present in the final product. Therefore, the FEEDAP Panel concludes that L-Threonine produced using E. coli CGMCC 3703 does not raise any safety concern for the target species, consumer, user and the environment with regard to the genetic modification of the production strain. The FEEDAP Panel reiterated their concerns on the safety of amino acids, including L-Threonine, for target species when administered simultaneously via water for drinking due to amino acid imbalances. As the estimated maximum exposure to endotoxins by inhalation was below the provisional occupational exposure limit, no risk from the exposure to endotoxins for people handling the additive is expected. [ABSTRACT FROM AUTHOR]

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 59 flavouring substances in the Flavouring Group Evaluation 21, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of the assessment of new toxicity data on one supporting substance 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H- 1,3,5-dithiazine [FL-no: 15.113], which is considered to be structurally related to the candidate substances 2- butyl-4-methyl(4H)pyrrolidino[1,2d]-1,3,5-dithiazine [FL-no: 15.042], dihydro-2,4,6-triethyl-1,3,5(4H)- dithiazine [FL-no: 15.054], 2,4-dimethyl(4H)pyrrolidino[1,2e]-1,3,5-dithiazine [FL-no: 15.055], 4,6-dimethyl-2- (1-methylethyl)dihydro-1,3,5-dithiazine [FL-no: 15.057], 2-isobutyldihydro-4,6-dimethyl-1,3,5-dithiazine [FLno: 15.079] and ethyl thialdine [FL-no: 15.135]. Furthermore, new in vitro genotoxicity studies have become available on the supporting substance 2-acetyl-2-thiazoline [FL-no: 15.010], which is considered to be structurally related to and a supportive substance for 2-methyl-2-thiazoline [FL-no: 15.086]. Eighteen of the original 59 candidate substances [FL-no: 15.037, 15.042, 15.043, 15.064, 15.070, 15.072, 15.077, 15.088, 15.090, 15.091, 15.092, 15.094, 15.099, 15.106, 15.107, 15.114, 15.129 and 15.133], for which additional data were requested, are no longer supported by Industry for use as flavouring substances in Europe and will therefore not be considered any further. Therefore, FGE.21Rev4 will only deal with 41 candidate substances. Two of the substances, 3-thiazolines, 2,4-dimethyl-3-thiazoline [FL-no: 15.060] and 2-isobutyl-3-thiazoline [FLno: 15.119], were considered to have genotoxic potential. The remaining 39 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that 32 flavouring substances [FL-no: 15.038, 15.039, 15.044, 15.050, 15.051, 15.052, 15.054, 15.055, 15.057, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.078, 15.079, 15.080, 15.082, 15.084, 15.085, 15.086, 15.087, 15.089, 15.098, 15.108, 15.115, 15.116, 15.118 and 15.135] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining seven candidate substances [FL-no: 15.040, 15.045, 15.074, 15.076, 15.093, 15.096 and 15.097] evaluated through the Procedure, no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 41 candidate substances. [ABSTRACT FROM AUTHOR]

The article discusses the reasons as to why some European countries are not at par with others in health care implementations. The reasons for the difference vary from availability of resources to unwillingness to reform several areas of health care including alcohol use, infant mortality, and breast cancer. The article highlights the need for effective government and public health workforce and uses examples from several countries across Europe including Belgium, Russia, and Albania. INSET: Box 2 | Potential years of life lost in excess of those in....

The article presents a study that evaluated the impact of organizational and cultural characteristics of hospitals on the quality of health care. A longitudinal case study and in-depth multi-level analysis of healthcare quality policies in European hospitals were conducted. Findings suggested that the features associated with better quality of care may affect the clinical effectiveness, patient safety and patient experience.

Reports on DG SANCO, the Consumer Affairs Directorate of the European Commission's financing of a project related to toy safety to promote the interest of consumers.

Aim To use an evidence-based approach to evaluate the safety and tolerability of the treatments available for irritable bowel syndrome (IBS), or in clinical development, in Europe. A separate review appraises the evidence for the efficacy of these therapies. Methods A literature search (for 1980 to 2005) was completed for all relevant clinical trial data and other articles which included safety information on the use of pharmacological IBS therapies. Clinical trials were scored according to the level of safety information, and adverse event incidence reported when possible. Results The tolerability of many of the agents used to treat IBS in Europe is poorly understood. However, serotonergic agents, such as tegaserod and alosetron, which are currently unavailable in Europe, have undergone rigorous assessment in IBS and their benefits have been established. Following initial marketing of alosetron for use in patients with IBS with diarrhoea, concerns about severe constipation and ischaemic colitis resulted in restriction of its use to women with severe IBS symptoms. This highlights the importance of post-marketing surveillance and post-marketing studies in refining the therapeutic indication of new IBS therapies, which will help to identify appropriate recipients for the drug and establish the impact of adverse reactions in clinical practice. Conclusions There is a significant lack of data on the safety and tolerability of the therapies currently used routinely to treat IBS in Europe. The newer agents have undergone rigorous assessment, such that their benefits and risks in treating IBS are established. Defining their place among the spectrum of available therapies remains challenging when the benefits and risks of the older treatments are so poorly characterized. [ABSTRACT FROM AUTHOR]

The article focuses on a Directive on General Product Safety in Europe in 1992. The aim of the directive is to establish technical standards for consumer products. In 2001 a revised Directive has been issued. Businesses need to comply with product safety requirements. They also have to inform regulators of problems.

Following the adoption of new international sampling conventions for inhalable, thoracic and respirable aerosol fractions, a working group of Comité Européen de Normalisation (CEN) drafted a standard for the performance of workplace aerosol sampling instruments. The present study was set up to verify the experimental, statistical and mathematical procedures recommended in the draft performance standard and to check that they could be applied to inhalable aerosol samplers. This was achieved by applying the tests to eight types of personal inhalable aerosol sampler commonly used for workplace monitoring throughout Europe. The study led to recommendations for revising the CEN draft standard, in order to simplify the tests and reduce their cost. However, some further work will be needed to develop simpler test facilities and methods. Several of the samplers tested were found to perform adequately with respect to the inhalable sampling convention, at least over a limited range of typical workplace conditions. In general the samplers were found to perform best in low external wind speeds, which are the test conditions thought to be closest to those normally found in indoor workplaces. The practical implementation of the CEN aerosol sampling conventions requires decisions on which sampling instruments to use, estimation of the likely impact that changing sampling methods could have on apparent exposures, and adjustment where necessary of exposure limit values. The sampler performance data obtained in this project were affected by large experimental errors, but are nevertheless a useful input to decisions on how to incorporate the CEN inhalable sampling convention into regulation, guidance and occupational hygiene practice. Crown Copyright © 1997 Published by Elsevier Science Ltd. [ABSTRACT FROM AUTHOR]

The article reports on the new approach adopted by the European Medicines Agency in providing scientific advice on the research and development of new medicines. The agency's Scientific Advice Working Party provides scientific advice on development of new therapies which includes specific expertise in preclinical safety, pharmacokinetics and therapeutic fields.

The section presents several studies on social patterning of injury risks. A study on social differences in injuries of various kinds is presented. Moreover, a research on the mechanism of social inequality in safety is explored. The mechanisms include social stratification, differential exposure, differential susceptibility and differential consequences. The impact of injuries on childhood mortality in European countries is also investigated.