The impact of the European health and safety directives on engineering in higher education

NASA Astrophysics Data System (ADS)

Crisp, Alan Roy

This thesis examines the effect that six sets of Health and Safety legislation introduced in 1993 have had on working practices at the University, particularly within the Engineering Departments. The legislation, collectively known colloquially as "the six pack", had much in common with extant United Kingdom (UK) law but, because it emanated from the European Union (EU), it appears to be viewed in the UK as unduly restrictive and time consuming. Much of the thesis is therefore devoted to examining this suspicion in which the EU and its legislation is held by UK employers and employees. The thesis begins by examining the general background and recent history of the EU, before going on to look in greater detail at the development of Health and Safety legislation in particular. The area of interest is then further narrowed to look at the impact of this legislation on Higher Education Institutions by comparing recent accident statistics with those for industry and commerce. The main outcome of this section is that Higher Education has a similar accident profile by 'type' to industry and commerce and therefore would act in a similar manner when implementing the legislation. It is argued that industry and commerce can benefit from this similarity by emulating two case studies at the University where legislation is applied to some engineering equipment and procedures. These are described in detail and the point is made that safety is an approach that pervades all stages of an engineering process, commencing with the design or ordering of equipment. This is reinforced with the results of a primary survey of purchasing at similar institutions with regards to observance of current safety practices. It is concluded that suspicion of the "six pack" legislation is largely the result of overloading of those people responsible for safety by the arrival of a plethora of legislation all at once. Ironically this overloading appears to have influenced safety officers to pay attention to one part of the legislation at a time rather than take the integrated approach that was intended. This has further increased the workload with much testing and replacement of equipment taking place unnecessarily, as would be realised if all legislation were being applied simultaneously. The usefulness of this thesis therefore lies in showing that an integrated approach to Health and Safety is simply part of an overall integrated approach by the EU to increasing prosperity through responsible, sustainable economic development and is not intended to restrict productivity.

European activities in radiation protection in medicine.

PubMed

Simeonov, Georgi

2015-07-01

The recently published Council Directive 2013/59/Euratom ('new European Basic Safety Standards', EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom 'BSS' and the 97/43/Euratom 'Medical Exposure' Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe-these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (non-medical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is launching several actions including promotion and dissemination activities, exchange and discussion fora and provision of guidance. These actions will be based on previous experiences and will rely on the results of recent and ongoing EU-funded projects. Important stakeholders including the Euratom Article 31 Group, the association of the Heads of European Radiological protection Competent Authorities (HERCA) and different European professional and specialty organisations will be involved. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Rabies Vaccination: Higher Failure Rates in Imported Dogs than in those Vaccinated in Italy.

PubMed

Rota Nodari, E; Alonso, S; Mancin, M; De Nardi, M; Hudson-Cooke, S; Veggiato, C; Cattoli, G; De Benedictis, P

2017-03-01

The current European Union (EU) legislation decrees that pets entering the EU from a rabies-infected third country have to obtain a satisfactory virus-neutralizing antibody level, while those moving within the EU require only rabies vaccination as the risk of moving a rabid pet within the EU is considered negligible. A number of factors driving individual variations in dog vaccine response have been previously reported, including a high rate of vaccine failure in puppies, especially those subject to commercial transport. A total of 21 001 observations collected from dogs (2006-2012) vaccinated in compliance with the current EU regulations were statistically analysed to assess the effect of different risk factors related to rabies vaccine efficacy. Within this framework, we were able to compare the vaccination failure rate in a group of dogs entering the Italian border from EU and non-EU countries to those vaccinated in Italy prior to international travel. Our analysis identified that cross-breeds and two breed categories showed high vaccine success rates, while Beagles and Boxers were the least likely to show a successful response to vaccination (88.82% and 90.32%, respectively). Our analysis revealed diverse performances among the commercially available vaccines, in terms of serological peak windows, and marked differences according to geographical area. Of note, we found a higher vaccine failure rate in imported dogs (13.15%) than in those vaccinated in Italy (5.89%). Our findings suggest that the choice of vaccine may influence the likelihood of an animal achieving a protective serological level and that time from vaccination to sampling should be considered when interpreting serological results. A higher vaccine failure in imported compared to Italian dogs highlights the key role that border controls still have in assessing the full compliance of pet movements with EU legislation to minimize the risk of rabies being reintroduced into a disease-free area. © 2016 The Authors. Zoonoses and Public Health Published by Blackwell Verlag GmbH.

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

PubMed Central

Jokura, Yoji; Yano, Kazuo

2017-01-01

Abstract Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited‐approval pathways, and obligations to collect and report post‐marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time‐limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre‐ or post‐marketing clinical data. Expedited‐approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post‐marketing study for conditional and time‐limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited‐approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. PMID:28211195

Legislative and ethical aspects of introducing new technologies in medical care for senior citizens in developed countries.

PubMed

Kacetl, Jaroslav; Maresova, Petra

2016-01-01

The majority of developed countries are currently experiencing demographic aging. The most frequently expressed concerns related to the changing age structure are the increased costs of social and medical care, a lack of labor force in the job market, and financial sustainability of the pension system. These concerns are often based on the pessimistic view of population aging. This view understands aging as a prolonged period of illness and suffering. On the other hand, optimists believe that a longer life span is a result of increased quality of life and better health care. The quality of life may be improved not only by medicaments, but also by rapidly developing area of medical devices, which allow better care for seniors in many areas. This contribution aims to assess the legislative environment and ethical questions related to the use of medical devices, especially medical devices, in medical care for senior citizens. The methods used in this study are literature reviews of legislative and ethical environment in the European Union (EU) and the US. Main findings of this study result from assessing the state of medical device regulations in Europe and the US. Namely, the US regulation seems to be better arranged, which is probably due to the fact that there is only one responsible body - the US Food and Drug Administration, which is responsible for all medical device regulations. On the other hand, in the EU, talks about new legislation are led by ministers from all the EU member states and it may take a long time before all the EU countries come to an agreement.

Legislative and ethical aspects of introducing new technologies in medical care for senior citizens in developed countries

PubMed Central

Kacetl, Jaroslav; Maresova, Petra

2016-01-01

Introduction The majority of developed countries are currently experiencing demographic aging. The most frequently expressed concerns related to the changing age structure are the increased costs of social and medical care, a lack of labor force in the job market, and financial sustainability of the pension system. These concerns are often based on the pessimistic view of population aging. This view understands aging as a prolonged period of illness and suffering. On the other hand, optimists believe that a longer life span is a result of increased quality of life and better health care. The quality of life may be improved not only by medicaments, but also by rapidly developing area of medical devices, which allow better care for seniors in many areas. Aim This contribution aims to assess the legislative environment and ethical questions related to the use of medical devices, especially medical devices, in medical care for senior citizens. Methods The methods used in this study are literature reviews of legislative and ethical environment in the European Union (EU) and the US. Results Main findings of this study result from assessing the state of medical device regulations in Europe and the US. Namely, the US regulation seems to be better arranged, which is probably due to the fact that there is only one responsible body – the US Food and Drug Administration, which is responsible for all medical device regulations. On the other hand, in the EU, talks about new legislation are led by ministers from all the EU member states and it may take a long time before all the EU countries come to an agreement. PMID:27499618

Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries.

PubMed

Amenta, Valeria; Aschberger, Karin; Arena, Maria; Bouwmeester, Hans; Botelho Moniz, Filipa; Brandhoff, Puck; Gottardo, Stefania; Marvin, Hans J P; Mech, Agnieszka; Quiros Pesudo, Laia; Rauscher, Hubert; Schoonjans, Reinhilde; Vettori, Maria Vittoria; Weigel, Stefan; Peters, Ruud J

2015-10-01

Nanotechnology has the potential to innovate the agricultural, feed and food sectors (hereinafter referred to as agri/feed/food). Applications that are marketed already include nano-encapsulated agrochemicals or nutrients, antimicrobial nanoparticles and active and intelligent food packaging. Many nano-enabled products are currently under research and development, and may enter the market in the near future. As for any other regulated product, applicants applying for market approval have to demonstrate the safe use of such new products without posing undue safety risks to the consumer and the environment. Several countries all over the world have been active in examining the appropriateness of their regulatory frameworks for dealing with nanotechnologies. As a consequence of this, different approaches have been taken in regulating nano-based products in agri/feed/food. The EU, along with Switzerland, were identified to be the only world region where nano-specific provisions have been incorporated in existing legislation, while in other regions nanomaterials are regulated more implicitly by mainly building on guidance for industry. This paper presents an overview and discusses the state of the art of different regulatory measures for nanomaterials in agri/feed/food, including legislation and guidance for safety assessment in EU and non-EU countries. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Advertising of medical devices: foreign experience and Ukrainian practice.

PubMed

Pashkov, Vitalii; Harkusha, Andrii; Bytiak, Oleksii

Chosen European foreign policy vector for Ukraine establishes its obligation to enforce the process of adaptation of the EU law regulations in the internal legal policy. The approximation of Ukrainian law to the European Union (EU) "acquis communautaire" is not only the instrument for deepening our economic cooperation with the European Union, but also the important measure to enhance further development of Ukraine in general. National legislation, which regulate advertising and promotion of medical devices (MD), is not an exception. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Law Acts, EU's member-states law, WHO Acts and Recommendations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. In accordance with Ukrainian legislation, there is no special law that concerns advertising on MD in Ukraine, this sphere is regulated by general law that named ≪About advertisement≫, but it doesn't take into account even main characteristics of such a special object as medical devices (MD). Moreover, the law ≪About advertisement≫ contain discrepancies in terms that are used, these contradictions, in our opinion, must be eliminated by appropriate law reforms. The advertising and promotion of MD in EU is regulated by a combination of EU and national legislation of EU Member States, national advertising and promotion of MD are not harmonized with the EU MDD for now, resulting in a fragmented legal landscape that differs from one EU Member State to the other. Practice of adopting different codes and guides that regulate advertising, including advertising of MD, is widespread in EU and EU Member States and thus must be used in Ukraine with appropriate reformation of national law.

Nanomaterials in Food - Current and Future Applications and Regulatory Aspects

NASA Astrophysics Data System (ADS)

Aschberger, K.; Gottardo, S.; Amenta, V.; Arena, M.; Botelho Moniz, F.; Bouwmeester, H.; Brandhoff, P.; Mech, A.; Quiros Pesudo, L.; Rauscher, H.; Schoonjans, R.; Vittoria Vettori, M.; Peters, R.

2015-05-01

Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry.

Food labelling: Regulations and Public Health implications.

PubMed

Marcotrigiano, V; Lanzilotti, C; Rondinone, D; De Giglio, O; Caggiano, G; Diella, G; Orsi, G B; Montagna, M T; Napoli, C

2018-01-01

Legislators have implemented policies to improve food labelling to protect consumers and to make the presentation of ingredients and nutritional information more transparent. Proper food labelling allows consumers who may suffer from food allergies or intolerances to know exactly what ingredients a product contains, and it also helps them make more informed health and nutrition choices. This paper deals with the most current European and Italian legislation on food labelling, actions taken in non-EU countries to increase health choices, and the expected impact on Public Health.

Evolution of European Union legislation on emergency research.

PubMed

Mentzelopoulos, Spyros D; Mantzanas, Michail; van Belle, Gerald; Nichol, Graham

2015-06-01

Emergency research is necessary to prevent exposure of patients to unvalidated clinical practice (nonmaleficence), and to improve the dismal prognosis of disorders requiring emergent treatment such as cardiac arrest (beneficence). Regulations that govern clinical research should conform to bioethical principles of respect for nonmaleficence, beneficence, autonomy, and justice. Our objectives are to review the evolution of European Union (EU) legislation on emergency research, and to identify potentially remaining problems. EU legislative sources on clinical research and medical literature describing the impact of EU Regulations on emergency research. Article 5 of EU Directive 2001/20/EC required consent before enrolment in a research study to ensure the autonomy of potentially incapacitated research subjects. However, obtaining such consent is often impossible in emergency situations. Directive 2001/20/EC was criticized for potentially preventing emergency research. Several EU Member States addressed this problem by permitting deferred consent. International ethical guidelines supporting deferred consent were also cited by Good Clinical Practice Directive 2005/28/EC. However, Directive 2001/20/EC was not revised to achieve harmonization of EU emergency research, thus resulting in ongoing "ambiguity" as regards to emergency research legitimacy. This will be definitively addressed by applying EU Regulation No. 536/2014 and repealing Directive 2001/20/EC. The new EU Regulation permits using deferred consent under clearly specified conditions, and may foster emergency research that evaluates interventions posing minimal risk relative to standard practice. Legislation related to emergency research in Europe has evolved to increase concordance with bioethical principles so as to increase evidence-based improvements in emergency care. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety.

PubMed

Coppens, Patrick; da Silva, Miguel Fernandes; Pettman, Simon

2006-04-03

This article describes the legislation that is relevant in the marketing of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication. Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation on dietetic foods, on food supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'nutraceuticals' in Europe. The cornerstone of EU legislation on food products, including functional foods and nutraceuticals is 'safety'. Decisions on the safety-basis of legislation are based on risk analysis, in which scientific risk assessment is performed by the European Food Safety Authority and risk management is performed by the European Commission, the Member States, and in case of legislation, together with the European Parliament. In the risk management phase, both the precautionary principle and other legitimate factors may be considered in choosing the best way of dealing with an issue. Due to the numerous pieces of legislation applying and to the different procedures to be followed, the process of having 'functional foods' ready for the market is certainly a costly and time-consuming task. However, it may also be clearly worth it in terms of market success and improved consumer health.

Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

PubMed Central

Penkov, Dobromir; Tomasi, Paolo; Eichler, Irmgard; Murphy, Dianne; Yao, Lynne P.; Temeck, Jean

2017-01-01

Pediatric legislation in the US and the EU is driving pediatric product development on an international scale. To facilitate harmonization and global development of pediatric medicines, it is important to understand the legislative requirements that must be met along with incentives that exist in the US and the EU to include pediatric patients in therapeutic clinical trials. Although there are many similarities, differences exist. This review is an effort to enhance understanding of the pediatric legislation in both regions. It is intended as an overview to supplement the region-specific legislation and guidance documents that are available on the websites of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Despite differences, the goal of the legislation in both the EU and the US is to incentivize and require timely, ethical, and sound scientific development of pharmaceutical products for the pediatric population and to provide information for their safe and effective use. PMID:28674673

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

PubMed

Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

2018-02-01

Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd.

Gambling in Spain: update on experience, research and policy.

PubMed

Jiménez-Murcia, Susana; Fernández-Aranda, Fernando; Granero, Roser; Menchón, Jose Manuel

2014-10-01

To describe the current situation of gambling in Spain, sketching its history and discussing the regulations and legislation currently in force within the framework of the European Union (EU), and to review the epidemiology of gambling in Spain, the self-help groups and professional treatments available, and their potential effectiveness. A systematic computerized search was performed in three databases (EMBASE, PubMed and PsychINFO, including articles and chapters) and the reference lists from previous reviews to obtain some of the most relevant studies published up to now on the topic of pathologic gambling in Spain. Similar to other EU countries, Spain has a high prevalence of pathologic gambling, focused on specific culturally bounded types of gambling. Expenditure in online gaming has risen significantly in the last few years, prompting the Spanish government to draft new legislation to regulate gaming. The gaming industry is expected to be one of the fastest growing sectors in Spain in the coming years owing to the rise of new technologies and the development of online gaming. © 2013 Society for the Study of Addiction.

An overview of Compassionate Use Programs in the European Union member states.

PubMed

Balasubramanian, Gayathri; Morampudi, Suman; Chhabra, Pankdeep; Gowda, Arun; Zomorodi, Behsad

2016-11-01

The past decade witnessed rapid development of novel drugs and therapeutic biological agents. The marketing authorization for novel therapies is often time consuming and distressing for patients. Earlier clinical trials were the only way to access new drugs under development. However, not every patient meets the enrolment criteria, and participation is difficult for patients with life-threatening, long-lasting or seriously debilitating diseases like rare diseases. Early access programs like "Compassionate Use Program (CUP)" have generated alternative channels for such patients. The European Medical Agency provides regulations and recommendations for compassionate use, upon which every European Union (EU) member state has developed its own rules and regulations. Despite previous reviews and studies, the available information is limited and gaps exist. This literature review explores CUP in 28 EU member states. Data was collected through literature review and use of country-specific search terms from the healthcare domain. Data sources were not limited to databases and articles published in journals, but also included grey literature. The results implied that CUP was present in 20 EU member states (71%). Of 28 EU states, 18 (∼64%) had nationalized regulations and processes were well-defined. Overall, this review identified CUP and its current status and legislation in 28 EU member states. The established legislation for CUP in the EU member states suggest their willingness to adopt processes that facilitate earlier and better access to new medicines. Further research and periodic reviews are warranted to understand the contemporary and future regulatory trends in early access programs.

[Drugs in the European Union: the health-market complex].

PubMed

Antoñanzas, Fernando; Rodríguez, Roberto; Sacristán, José Antonio; Illa, Rafael

2005-01-01

To characterize the peculiar economic nature of the pharmaceutical market in the EU, to study potential groupings of countries based on several pharmaceutical variables, to analyze some recent regulations designed to create the single market, and to present some thoughts on the decision making process in public health from the perspective of current public health budgets. We performed an economic analysis of health and pharmaceutical macrovariables, cluster analysis, review of EU pharmaceutical and industrial regulations and review of pharmaceutical budgeting legislation in the member states. The pharmaceutical market of the EU was characterized and EU countries were classified into two principal groups according to 5 selected variables. EU regulations tend to promote R + D and drug production and thus the EU industrial sector is backed up. National regulations differ in terms of pricing and drugs reimbursement. The creation of a single market for drugs in the EU should take this regulatory diversity into account and seek equilibrium between economic factors and public health. This single market may be a dangerous strategy if it becomes a general dogma and even more so if deadlines are fixed and short.

Environmental assessment of microwaves and the effect of European energy efficiency and waste management legislation.

PubMed

Gallego-Schmid, Alejandro; Mendoza, Joan Manuel F; Azapagic, Adisa

2018-03-15

More than 130 million microwaves are affected by European Union (EU) legislation which is aimed at reducing the consumption of electricity in the standby mode ('Standby Regulation') and at more sustainable management of end-of-life electrical and electronic waste ('WEEE Directive'). While legislation focuses on these two life cycle stages, there is little information on the environmental impacts of the entire life cycle of microwaves. To address this gap, this paper presents a comprehensive life cycle assessment of microwaves and assesses the environmental implications of the Standby Regulation and the WEEE Directive at the EU level. The impacts are first considered at the level of individual appliances and then at the EU level, with the aim of evaluating the potential environmental implications of the full implementation of the above two EU regulations by 2020. The effects of the electricity decarbonisation and the expected increase in the number of microwaves in use have also been considered. The results suggest that implementation of the EU regulation by 2020 will reduce the environmental impacts considered by 4%-9% compared to the current situation. The majority of these reductions is due to the Standby Regulation, with the contribution of the WEEE Directive being small (~0.3%). However, the expected decarbonisation of electricity will result in much higher reductions (6%-24%) for most impact categories. The results also show that the materials used to manufacture the microwaves, the manufacturing process and end-of-life disposal are environmental hot-spots for several impacts, including depletion of abiotic elements. Therefore, efforts to reduce the environmental impacts of a future electricity mix should be combined with the development of specific eco-design regulations for microwaves that stipulate optimisation of resource consumption. Possible future trends, such as shorter lifetimes and limited availability of some resources, make the development of such product regulations more critical. Copyright © 2017 Elsevier B.V. All rights reserved.

Dietary Supplements: Foods, Medicines, or Both? A Controversial Designation with Unspecific Legislation.

PubMed

Pereira, Carla; Barros, Lillian; Ferreira, Isabel C F R

2017-01-01

Dietary supplements have been widely used among the United States of America (USA) and the European Union (EU) population not only as a form of nutrition but also for medicinal purposes. Still, the legislation regulating these supplements remains unclear due to the fact that they can be considered as foodstuffs and/or medicinal products depending on various factors. The present review article intends to provide information concerning the variations on the definition of dietary supplements, the allowable substances on it, as well as the marketing and labelling requirements among the USA and the EU legislation. In fact, several discrepancies can be found between regulations in the USA (mainly regulated by the Food and Drugs Administration) and in the EU (principally regulated by the Food Supplements Directive or by the Directive 2001/83/EC), and even between the different Member States of the EU, with the main differences observed in new products marketing requirements. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Evidence based policy making in the European Union: the role of the scientific community.

PubMed

Majcen, Špela

2017-03-01

In the times when the acquis of the European Union (EU) has developed so far as to reach a high level of technical complexity, in particular in certain policy fields such as environmental legislation, it is important to look at what kind of information and data policy decisions are based on. This position paper looks at the extent to which evidence-based decision-making process is being considered in the EU institutions when it comes to adopting legislation in the field of environment at the EU level. The paper calls for closer collaboration between scientists and decision-makers in view of ensuring that correct data is understood and taken into consideration when drafting, amending, negotiating and adopting new legal texts at all levels of the EU decision-making process. It concludes that better awareness of the need for such collaboration among the decision-makers as well as the scientific community would benefit the process and quality of the final outcomes (legislation).

Giving information on medicinal products to the general public--in search of a definition to safeguard the patient.

PubMed

Faeh, Andrea

2014-04-01

Information on medicinal products is vital for enabling patients to give informed consent to the use of a specific product. Within the European Union (EU) the debate about how much information about prescription-only medicinal products should be made available to patients has gone on for the past five years with no definite conclusion yet. This contribution assesses the current legislation and the ongoing debate in order to identify the challenges and the prospect of new legislation, and consider its potential implications for the scope for advertising and for patient safety.

Marine legislation--the ultimate 'horrendogram': international law, European directives & national implementation.

PubMed

Boyes, Suzanne J; Elliott, Michael

2014-09-15

The EU is a pre-eminent player in sustainable development, adopting more than 200 pieces of legislation that have direct repercussions for marine environmental policy and management. Over five decades, measures have aimed to protect the marine environment by tackling the impact of human activities, but maritime affairs have been dealt with by separate sectoral policies without fully integrating all relevant sectors. Such compartmentalisation has resulted in a patchwork of EU legislation and resultant national legislation leading to a piecemeal approach to marine protection. These are superimposed on international obligations emanating from UN and other bodies and are presented here as complex 'horrendograms' showing the complexity across vertical governance. These horrendograms have surprised marine experts despite them acknowledging the many uses and users of the marine environment. Encouragingly since 2000, the evolution in EU policy has progressed to more holistic directives and here we give an overview of this change. Copyright © 2014 Elsevier Ltd. All rights reserved.

An Assessment of Coherence Between Early Warning and Response Systems and Serious Cross-Border Health Threats in the European Union and Turkey

PubMed Central

Elif Ekmekci, Perihan

2017-01-01

Disease outbreaks have attracted the attention of the public health community to early warning and response systems (EWRS) for communicable diseases and other cross-border threats to health. The European Union (EU) and the World Health Organization (WHO) have published regulations in this area. Decision 1082/2013/EU brought a new approach the management of public health threats in EU member states. Decision 1082/2013/EU brought several innovations, which included establishing a Health Security Committee; preparedness and response planning; joint procurement of medical countermeasures; ad hoc monitoring for biological, chemical, and environmental threats; EWRS; and recognition of an emergency situation and interoperability between various sectors. Turkey, as an acceding country to the EU and a member of the WHO, has been improving its national public health system to meet EU legislations and WHO standards. This article first explains EWRS as defined in Decision 1082/2013/EU and Turkey’s obligations to align its public health laws to the EU acquis. EWRS in Turkey are addressed, particularly their coherence with EU policies regarding preparedness and response, alert notification, and interoperability between health and other sectors. Finally, the challenges and limitations of the current Turkish system are discussed and further improvements are suggested. PMID:27511433

Can TTIP Improve Laboratory Animal Welfare in Safety Testing and 3Rs?

PubMed

Busquet, Francois; Zurlo, Joanne; Hartung, Thomas

2016-05-01

In the context of the current negotiations between the European Union (EU) and the United States under the Transatlantic Trade Investment Partnership (TTIP), there is the opportunity to look at both legislative frameworks to better pinpoint convergences, synergies, and gaps when it comes to use of laboratory animals for scientific purposes and bring together the best of both worlds. The objectives in this article are to indicate what are the current EU pieces of legislation that are relevant under TTIP regarding the uses of laboratory animals for scientific purposes under the regulations about cosmetics and chemicals, among others. The same approach will be taken to look at the relevant American legal frameworks, that is, the Food and Cosmetics Act and the Toxic Safety Control Act as well as its most recent reauthorization. In conclusion, the authors will identify future frameworks that can contribute to the harmonization of regulatory standards and further steps where TTIP negotiators should strengthen regulatory cooperation. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Brexit and dentistry.

PubMed

Sinclair, E; Stagnell, S; Shah, S

2016-05-27

On 23 June 2016, eligible UK voters will be asked to decide whether to vote in the EU referendum. The EU impacts on our daily lives in more ways than many people realise. Dentistry is affected by EU legislation. Examples include the movement of dental professionals, the import of dental equipment and materials, as well as health and safety legislation. Many more EU dentists and DCPs come to the UK to work than vice versa. These numbers have increased markedly since 2004. The result of the vote may affect how dentistry operates in the UK in future years. In addition, a vote to stay would not necessarily prevent change. There are attempts underway to increase the ease by which professionals can work in other member states, especially on a temporary basis. This too is likely affect dentistry at some point. Workforce planners and policy makers should factor in the impact of the EU in future dental policy.

Assisted reproductive technologies are an integrated part of national strategies addressing demographic and reproductive challenges.

PubMed

Ziebe, Søren; Devroey, Paul

2008-01-01

The decline in the total fertility rate in the latter half of the 20th century in many European countries is becoming increasingly important in determining the demographic composition of Europe and its individual member states. This review focuses on discussion surrounding how assisted reproductive technology (ART) can impact declining fertility rates. This article summarizes key aspects of presentations given at the 'State of the ART 2007-ART and Society' meeting held in Lyon, France, in June 2007. For each topic, searches were conducted in MEDLINE and other databases and the results, alongside unpublished data and personal opinion, were presented to the Workshop Group. Individual subjects were discussed and any disagreements or omissions resolved. Although reduced fertility rates will have an impact on total population number, it is the change in the age structure of the population that is likely to be the most challenging factor faced by the European Union (EU). With evidence suggesting that an ageing population threatens future standards of living and social cohesion, managing demographic change through integrated policy response has become an important component of EU legislation. However, current measures fail to tackle the contribution that ART may play in alleviating falling fertility rates. Indeed, ART can have an important impact on economic and demographic factors, and should be incorporated into a population policy mix. Current barriers to ART include legislative restriction across different EU countries, limited availability to ART and current perception of ART in society. The inclusion of ART as part of a population policy mix in Europe is justified but must involve better communication among ART professionals, politicians and the general public.

The Commission White Paper on a Strategy for a Future EU Chemicals Policy: the view of European companies of American parentage.

PubMed

Montfort, Jean-Philippe

2003-04-01

After years of good service, EU legislation on chemicals is currently subject to a major review. This process, initiated by the Council of Ministers at Chester in April 1998, will soon lead to new legislative proposals. In the meantime, a review of the Commission's White Paper on "Strategy for a Future Chemicals Policy," published in February 2001, clearly shows that the regulatory landscape in this area will be significantly reshaped and that a new burden will be imposed on industry to demonstrate that the production and use of chemicals indeed conform to high standards of protection of human health and the environment. In the view of industry, on both sides of the Atlantic, while the objectives of the proposed reform can be supported, the measures proposed in the White Paper to implement these objectives are not properly balanced and will lead to substantial societal and economic drawbacks, unless significant adjustments are made. The purpose of this article is to present the pitfalls and difficulties of the reform as they are perceived by the EU Committee of the American Chamber of Commerce in Brussels, an organization that regroups about 150 European companies of American parentage, belonging to a broad range of European business sectors, including producers and users of chemicals. In view of the transatlantic and cross-business character of its membership, the EU Committee offers a different perspective on the debate.

New EU legislation for risk assessment of GM food: no scientific justification for mandatory animal feeding trials.

PubMed

Kuiper, Harry A; Kok, Esther J; Davies, Howard V

2013-09-01

This commentary focuses on the potential added value of and need for (sub)-chronic testing of whole genetically modified (GM) foods in rodents to assess their safety. Such routine testing should not be required since, due to apparent weaknesses in the approach, it does not add to current risk assessment of GM foods. Moreover, the demand for routine testing using animals is in conflict with the European Union (EU) Commission's efforts to reduce animal experimentation. Regulating agencies in the EU are invited to respect the sound scientific principles applied to the risk assessment of foods derived from GM plants and not to interfere in the risk assessment by introducing extra requirements based on pseudo-scientific or political considerations. © 2013 Society for Experimental Biology, Association of Applied Biologists and John Wiley & Sons Ltd.

EU legislations affecting safety data availability of cosmetic ingredients.

PubMed

Pauwels, Marleen; Rogiers, Vera

2007-12-01

With the introduction of the 6th and 7th Amendments (OJ L151, 32-37, 23 June 1993; OJ L066, 26-35, 11 March 2003) to the Cosmetic Products Directive (OJ L262, 169-200, 27 September 1976), imposing a testing and marketing ban on cosmetic products tested on animals, the retrieval of toxicological data on individual ingredients became of greater need. Since the majority of cosmetic ingredients are used for many other purposes than their cosmetic function, they fall under the scope of more than one EU Directive. An overview is given of EU legislation that could potentially affect the availability and interpretation of cosmetic safety data. It will become clear that, although cosmetics are regulated by a specific so-called "vertical" legislation, "horizontal" influences from other products' legislations play a role since they determine the type and amount of data that theoretically could be found on the specific substances they regulate. This knowledge is necessary while performing extended searches in databases and becomes indispensable when initiating negotiations with manufacturers or suppliers for obtaining the safety data required.

Overview of the current status of genetically modified plants in Europe as compared to the USA.

PubMed

Brandt, Peter

2003-07-01

Genetically modified crops have been tested in 1,726 experimental releases in the EU member states and in 7,815 experimental releases in the USA. The global commercial cultivation area of genetically modified crops is likely to reach 50 million hectares in 2001, however, the commercial production of genetically modified crops in the EU amounts to only a few thousand hectares and accounts for only some 0.03% of the world production. A significant gap exists between the more than fifty genetically modified crop species already permitted to be cultivated and to be placed on the market in the USA, Canada and other countries and the five genetically modified crop species permitted for the same use in the EU member states, which are still pending inclusion in the Common Catalogue of agricultural plant species. The further development of the "green gene technology" in the EU will be a matter of public acceptance and administrative legislation.

Surveillance and control of communicable diseases related to passenger ships in Europe.

PubMed

Hadjichristodoulou, Christos; Mouchtouri, Varvara A; Martinez, Carmen Varela; Nichols, Gordon; Riemer, Tobias; Rabinina, Jelena; Swan, Corien; Pirnat, Nina; Sokolova, Ona; Kostara, Elina; Rachiotis, George; Meilicke, Rainer; Schlaich, Clara; Bartlett, Christopher Lr; Kremastinou, Jenny; Partnership, The Shipsan

2011-01-01

This study was conducted within the European SHIPSAN (ship sanitation) project and aims at exploring the legislative framework and current practices related to surveillance of communicable diseases and response aboard passenger ships in Europe. A detailed questionnaire was disseminated and completed by 59 competent authorities in 27 European countries. The majority of competent authorities used national legislation without special provisions for passenger ships. Only 20% had specific provisions for ships regarding quarantine, while a smaller proportion of new Member States (MS) have specific legislation in comparison with old MS (p = 0.01). The Maritime Declaration of Health (MDH) was the main reporting tool used. About 30.5% of the competent authorities declared that they require submission of MDH by all arriving ships, but 28.8% only from affected areas, and 11.9% never require MDH. A total of 45 outbreaks or incidents (36 gastrointestinal, 1 incident of legionellosis, 3 respiratory, and 1 influenza-like illness outbreak, occupational tuberculosis, varicella, scabies, and meningitis) were reported to EU competent authorities during 2006. About 75% of the responders stated that there are gaps in the surveillance and control of communicable diseases. A diversity of approaches in EU countries, and gaps regarding surveillance and response and training needs of personnel were identified.

An Assessment of Coherence Between Early Warning and Response Systems and Serious Cross-Border Health Threats in the European Union and Turkey.

PubMed

Ekmekci, Perihan Elif

2016-12-01

Disease outbreaks have attracted the attention of the public health community to early warning and response systems (EWRS) for communicable diseases and other cross-border threats to health. The European Union (EU) and the World Health Organization (WHO) have published regulations in this area. Decision 1082/2013/EU brought a new approach the management of public health threats in EU member states. Decision 1082/2013/EU brought several innovations, which included establishing a Health Security Committee; preparedness and response planning; joint procurement of medical countermeasures; ad hoc monitoring for biological, chemical, and environmental threats; EWRS; and recognition of an emergency situation and interoperability between various sectors. Turkey, as an acceding country to the EU and a member of the WHO, has been improving its national public health system to meet EU legislations and WHO standards. This article first explains EWRS as defined in Decision 1082/2013/EU and Turkey's obligations to align its public health laws to the EU acquis. EWRS in Turkey are addressed, particularly their coherence with EU policies regarding preparedness and response, alert notification, and interoperability between health and other sectors. Finally, the challenges and limitations of the current Turkish system are discussed and further improvements are suggested. (Disaster Med Public Health Preparedness. 2016;10:883-892).

Young people's perceptions of tobacco packaging: a comparison of EU Tobacco Products Directive & Ireland's Standardisation of Tobacco Act

PubMed Central

Babineau, Kate; Clancy, Luke

2015-01-01

Objectives To measure young people's perceptions of tobacco packaging according to two current pieces of legislation: The EU Tobacco Products Directive (TPD) and Ireland's Public Health (Standardisation of Tobacco Products) Act. Design Within-subject experimental cross-sectional survey of a representative sample of secondary school students. School-based pen and paper survey. Setting 27 secondary schools across Ireland, randomly stratified for size, geographic location, gender, religious affiliation and school-level socioeconomic status. Data were collected between March and May 2014. Participants 1378 fifth year secondary school students aged 16–17 in Ireland. Main outcome measures Young people's perceptions of attractiveness, health risk and smoker characteristics of packs according to EU and Irish branding and packaging guidelines. Results Packs with more branding elements were thought to be healthier than standardised packs for Silk Cut (χ2=158.58, p<0.001), Marlboro (χ2=113.65, p<0.001), and Benson and Hedges (χ2=137.95, p<0.001) brands. Generalized estimating equation binary regressions found that gender was a significant predictor of pack attractiveness for Silk Cut, with females being more likely to find the EU packs attractive (β=−0.45, p=0.007). Gender was a significant predictor for females with regards to the perceived popularity of the Silk Cut brand (β=−0.37, p=0.03). Conclusions The removal of brand identifiers, including colour, font and embossing, reduces the perceived appeal of cigarette packs for young people across all three tested brands. Packs standardised according to Irish legislation are perceived as less attractive, less healthy and smoked by less popular people than packs which conform to the EU TPD 2014 guidelines. PMID:26048206

Technical assistance development soil management policy in Croatia

NASA Astrophysics Data System (ADS)

Spruyt, Eva; Helsen, Stefan; Hambach, Patrick; Cuyvers, Lars

2014-05-01

As from the first of July 2013, Croatia became a EU member country and therefore has to comply with all the EU-rules (the "acquis") as defined in the European Council in Copenhagen in 1993. One of the aspects of this acquis is the protection and conservation of the soil and groundwater and the remediation of contaminated sites that cause human and environmental risks. On behalf of the Department of Environment, Nature and Energy of the Flemish government together with the Public Waste Agency of Flanders(OVAM), ECOREM was assigned to carry out this study. The scope of this study therefore focuses on the aspect of soil management that can be divided into two main policies, beïng the policy for the prevention of soil contamination from new activities(1) and the policy for the management and remediation of historical soil contamination from local sources like industrial sites(2). To form a soil management policy, Croatia must start from the legal obligations enforced by the European Union. One of the European Directives regulating the monitoring and protection of soil and groundwater is the new Industrial Emission Directive ('IED' - 2010/78/EU) from the 24th of November 2010. Whereas the framework of the Directive is larger than contamination of soil , the focus of this study was limited to soil contamination only. In order to comply with the existing EU policy contributing to soil protection, the regulations in the IED, the Croatian government needs to adapt existing legislations or apply new regulations regarding soil monitoring for the industrial activities. Also other EU Directives enforce actions contributing to soil protection. Therefore, a questionnaire with different sorts of questions was sent to the different stakeholders (environmental institutes, agencies, ministries,…). The results were interpreted and allowed Ecorem, being the environmental consultant, to evaluate the gaps in the environmental and soil management policy. This study gives advice on how to integrate these regulations in the existing legislation of Croatia within the current policy of Ministries and Agencies. Therefore an inventory study of the current environmental legislation and governmental organization has been carried out. The inventory study evaluates the process of implementing the EID and other Directives, within the new membership of Croatia in the EU. Taking into account the future Soil Framework Directive and the Proposal of 2010, the study makes suggestions to implement future regulations for the protection and monitoring of the soil and the groundwater for potentially soil-contaminating activities. Finally, the study makes suggestions on how to determine standards for contamination parameters, procedures, definitions, … Input for these needs were obtained through the stakeholders.

Comparative study of the methods used for treatment and final disposal of sewage sludge in European countries.

PubMed

Kelessidis, Alexandros; Stasinakis, Athanasios S

2012-06-01

Municipal wastewater treatment results to the production of large quantities of sewage sludge, which requires proper and environmentally accepted management before final disposal. In European Union, sludge management remains an open and challenging issue for the Member States as the relative European legislation is fragmentary and quite old, while the published data concerning sludge treatment and disposal in different European countries are often incomplete and inhomogeneous. The main objective of the current study was to outline the current situation and discuss future perspectives for sludge treatment and disposal in EU countries. According to the results, specific sludge production is differentiated significantly between European countries, ranging from 0.1 kg per population equivalent (p.e.) and year (Malta) to 30.8 kg per p.e. and year (Austria). More stringent legislations comparing to European Directive 86/278/EC have been adopted for sludge disposal in soil by several European countries, setting lower limit values for heavy metals as well as limit values for pathogens and organic micropollutants. A great variety of sludge treatment technologies are used in EU countries, while differences are observed between Member States. Anaerobic and aerobic digestion seems to be the most popular stabilization methods, applying in 24 and 20 countries, respectively. Mechanical sludge dewatering is preferred comparing to the use of drying beds, while thermal drying is mainly applied in EU-15 countries (old Member States) and especially in Germany, Italy, France and UK. Regarding sludge final disposal, sludge reuse (including direct agricultural application and composting) seems to be the predominant choice for sludge management in EU-15 (53% of produced sludge), following by incineration (21% of produced sludge). On the other hand, the most common disposal method in EU-12 countries (new Member States that joined EU after 2004) is still landfilling. Due to the obligations set by Directive 91/271/EC, a temporary increase of sludge amounts that are disposed in landfills is expected during the following years in EU-12 countries. Beside the above, sludge reuse in land and sludge incineration seem to be the main practices further adopted in EU-27 (all Member States) up to 2020. The reinforcement of these disposal practices will probably result to adoption of advanced sludge treatment technologies in order to achieve higher pathogens removal, odors control and removal of toxic compounds and ensure human health and environmental protection. Copyright © 2012 Elsevier Ltd. All rights reserved.

Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.

PubMed

Chin, William Wei Lim; Joos, Angelika

2016-12-01

Over the past two decades, there has been growing concern over the lack of proper medication for children. This review attempts to evaluate the current progress of EU Pediatric Regulation made since 2007. The lack of properly evaluated pediatric medication has for long been a source of concern in the European Union. The drugs that were used in the past were often not properly evaluated, and dosage was arbitrarily calculated. Therefore, it was necessary to establish the Pediatric Regulation (EC no. 1901/2006) in the EU which would mandate research for pediatric drugs. Current legislations in place not only require mandatory research by pharma industry but also have guidelines to direct the quality of pediatric research performed. The main aim of this regulation was to advance high-quality research and development of pediatric drugs, thereby increasing the availability of safe and effective drugs for children. It also aimed to improve the information available on existing pediatric drugs. It has been 9 years since the pediatric regulation was framed. The pharma industry now sees pediatric research as an integral process of development. Drug companies which develop plans for a new drug, new form of drug, new indication, or new route of administration for adults are obliged to integrate in their development plan similar research for pediatric populations as well. It is hoped that the implementation of the current legislation will be reflected better in the future by the marketing of better and safer drugs for the pediatric population. The upcoming assessment to the European Commission in 2017 will further inform us on the impact after 10 years implementation of the legislation. What is Known: • The lack of properly evaluated pediatric medication has for long been a source of concern in the European Union. • Therefore, it was necessary to establish the EU Pediatric Regulation which would mandate research for pediatric drugs. What is New: • It has been 9 years since the pediatric regulation was framed, and the teething problems are slowly being overcome and the regulation is being used with increasing confidence. • As the Regulation is due for revision in 2017, this paper gives a current perspective on the impact of the regulation on availability and access to medicine for children.

Authorisation within the European Union of vaccines against antigenically variable viruses responsible for major epizootic diseases.

PubMed

Mackay, D K J

2007-08-01

Antigenically variable viruses are responsible for some of the most contagious and economically important diseases that affect domestic livestock. The serious consequences of such diseases in terms of economic loss, and human and animal health, were clearly demonstrated by recent epizootics of foot and mouth disease, and outbreaks of avian influenza and bluetongue in the European Union (EU). For such diseases, government authorities need to be able to respond, if appropriate, by making use of vaccines that are suited to the epidemiological situation. The current EU regulatory framework is not well adapted for approval and maintenance of vaccines where the antigens included have to be chosen to reflect the epidemiological need. An extensive revision of the technical requirements for authorisation of veterinary medicinal products within the EU is currently underway. Additionally, a major revision of the regulations that control how such authorisations are kept up-to-date is about to start. This provides an ideal opportunity to introduce into EU legislation the concept of the 'multistrain dossier' whereby a potentially large number of approved strains may be included within a marketing authorisation and the final vaccines may be blended to include strains according to need. In addition, new strains may be added onto the marketing authorisation by means of a rapid regulatory procedure should new antigenic variants actually or potentially threaten the EU.

Environmental contaminants of emerging concern in seafood – European database on contaminant levels

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vandermeersch, Griet, E-mail: griet.vandermeersch@ilvo.vlaanderen.be; Lourenço, Helena Maria; Alvarez-Muñoz, Diana

Marine pollution gives rise to concern not only about the environment itself but also about the impact on food safety and consequently on public health. European authorities and consumers have therefore become increasingly worried about the transfer of contaminants from the marine environment to seafood. So-called “contaminants of emerging concern” are chemical substances for which no maximum levels have been laid down in EU legislation, or substances for which maximum levels have been provided but which require revision. Adequate information on their presence in seafood is often lacking and thus potential risks cannot be excluded. Assessment of food safety issuesmore » related to these contaminants has thus become urgent and imperative. A database ( (www.ecsafeseafooddbase.eu)), containing available information on the levels of contaminants of emerging concern in seafood and providing the most recent data to scientists and regulatory authorities, was developed. The present paper reviews a selection of contaminants of emerging concern in seafood including toxic elements, endocrine disruptors, brominated flame retardants, pharmaceuticals and personal care products, polycyclic aromatic hydrocarbons and derivatives, microplastics and marine toxins. Current status on the knowledge of human exposure, toxicity and legislation are briefly presented and the outcome from scientific publications reporting on the levels of these compounds in seafood is presented and discussed. - Highlights: • Development of a European database regarding contaminants of emerging concern. • Current status on knowledge of human exposure, toxicity and legislation. • Review on the occurrence of contaminants of emerging concern in seafood.« less

Symposium on "The challenge of translating nutrition research into public health nutrition". Session 4: Challenges facing the food industry in innovating for health. Regulatory challenges and opportunities for food innovation.

PubMed

Binns, Nino

2009-02-01

The primary role of the extensive and complex modern food legislation is to protect the consumer. Providing a framework for industry and enabling free trade are secondary aims. In the EU the 2006 Regulation on nutrition and health claims made on foods was adopted in December 2006. This Regulation defines detailed lists of permitted claims with precise conditions, requires foods making claims to meet specific nutrient profiles and requires the submission of a dossier for approval of new health claims. Nutrient profiles and an initial list of existing health claims will not be agreed until January 2009 and January 2010 respectively. The uncertainty about profiles and the initial list of claims as well as the prescriptive nature of the Regulation will have a major impact, some negative but some positive, on food innovation. Worldwide legislation on nutrition and health claims continues to develop. The current paper also provides an outline of some other key pieces of European legislation that affect food innovation. However, currently, all this legislation remains in development and up-to-date information can be sought from the reference material provided.

Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.

PubMed

Tomić, Sinisa; Sucić, Anita Filipović; Martinac, Adrijana Ilić

2010-01-01

European legislation for medicines places the emphasis on an assessment of quality, safety and efficacy during the procedure for the granting of marketing authorisations for medicines, in order to protect patient health. The integrated European regulatory system involves the participation of a network of experts from the agencies of the member states that takes part in the European procedures for the authorisation of medicines. On the way to full membership in the EU, candidate countries and potential candidates have to transpose and implement the European directives for medicinal products; they must also strengthen their scientific and administrative capacities. Croatia acquired good experience in implementing the simplified marketing authorisation procedure for medicines authorised in the EU pursuant to the New Collaboration Agreement between Drug Regulatory Authorities in Central and East European Countries (nCADREAC), which helps it to exchange information and prepare for the implementation of European procedures. However, there are still some provisions to transpose before actual full membership, and also dossier upgrading, in which the marketing authorisation holder has to harmonise its documentation about a medicinal product with the requirements of the directives, if a product already on the market was not previously approved in line with current European legislation. Collaboration with the European Medicines Agency (EMA) through an Instrument for Pre-Accession (IPA) provides candidate countries and potential candidates the opportunity for education and training in some regulatory activities as well as the participation of their representatives as observers in some EMA committees and working groups. Some characteristics of the national regulatory frameworks of the countries of South East Europe in their efforts to achieve harmonisation with EU legislation are presented in this paper. Copyright 2010 Elsevier Inc. All rights reserved.

Medical migration within Europe: opportunities and challenges.

PubMed

Ling, Kate; Belcher, Paul

2014-12-01

The free movement of European citizens to live and work within the European Union (EU) is one of the fundamental pillars of the European single market. Recent EU legislation on the recognition of professional qualifications (to take effect January 2016) updates the framework within which doctors and others can migrate freely between EU member states to practise their profession. UK organisations lobbied extensively to change aspects of the original proposals, in particular those that threatened to 'water down' public protection in the interest of free movement. The legislation finally adopted significantly increases safeguards for patients and the public. The revised law covers the rules to be applied by regulators on (for example) assuring language competence, warning 'blacklists' of practitioners subject to sanctions, 'fast track' registration based on mutual recognition of professional qualifications, agreed minimum education and training requirements for mutual recognition, and encouragement of continuing professional development. Drafting of detailed secondary legislation is ongoing and poses opportunities and challenges for patient safety, quality of care and transparency. © 2014 Royal College of Physicians.

The implementation of traceability systems.

PubMed

Ammendrup, S; Barcos, L O

2006-08-01

Traceability is a tool to help countries meet their objectives of controlling, preventing and eradicating animal diseases. This article sets out the required steps in a traceability system. Before designing a system of traceability, one must identify the different characteristics that need to be traced throughout the various steps in the food production chain. The interaction between different sectors in defining the objectives and the resulting needs of a traceability system is fundamental. A clear legal framework is also indispensable. European Union (EU) legislation requires identification and registration for cattle, pigs, sheep and goats. For intra-EU trade these animals must be accompanied by a health certificate providing information on their identity and health status. The required identification is harmonised on an EU-wide basis with the aim of ensuring traceability for veterinary purposes. Furthermore EU legislation requires that the traceability of food, feed and food-producing animals be established at all stages of production.

Bridging the divide between theory and guidance in strategic environmental assessment: A path for Italian regions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baresi, Umberto, E-mail: u.baresi@uq.edu.au

Clear and effective legislation is a requisite to bring sustainable development from theory into practice. This paper develops a methodology to investigate how Italian regional legislation disciplines the use of Strategic Environmental Assessment (SEA), the procedure used in the European Union (EU) to pursue sustainable development of policies, plans, and programs (PPPs). Our case study is the Italian regional level, examined to identify eventual flaws and areas for improvement for each regional legislative framework. For this purpose, this study refers to a selection of analytical criteria recurring in the international debate on sustainability assessments. Statistical multi-dimensional analysis is used tomore » identify Italian regions with similar SEA legislation. We recognize four taxonomies, depending on the way regional legislation provides information about i) legislation and guidelines, ii) integration between SEA and PPPs, iii) sustainability goals, iv) technical organization, v) participatory organization, and vi) monitoring. The results suggest that Italian administrators should cooperate to improve legislation at the regional level. Acknowledging the institution-centred nature of SEA, this methodology could drive the EU to better support SEA development in countries with diversified traditions.« less

Impact of the European paediatric legislation in paediatric rheumatology: past, present and future.

PubMed

Ruperto, Nicolino; Vesely, Richard; Saint-Raymond, Agnes; Martini, Alberto

2013-12-01

Conducting clinical trials in paediatric rheumatology has been difficult mainly because of the lack of funding for academic studies and the lack of interest by pharmaceutical companies in the small and non-rewarding paediatric market. The situation changed dramatically a few years ago with the introduction of the Best Pharmaceuticals for Children Act in the USA and of specific legislation for the development of paediatric medicines (Paediatric Regulation) in the European Union (EU). The EU Paediatric Regulation had a positive impact in paediatric rheumatology-in particular, on the development of new treatments for children with juvenile idiopathic arthritis (JIA). Some problems remain, however, such as greater harmonisation of the regulatory aspects of medicines, how to handle me-too agents, how to conduct adequate pharmacokinetic studies and develop age-appropriate formulations, ethical problems in study review and implementation, and a change in the current JIA classification. The introduction of specific legislation, coupled with the existence of large international networks such as the Pediatric Rheumatology Collaborative Study Group (PRCSG at http://www.prcsg.org), covering North America, and the Paediatric Rheumatology International Trials Organisation (PRINTO at http://www.printo.it), covering more than 50 countries, has led to great advances in paediatric rheumatology. Future changes might increase the possibility of conducting trials with similar approaches in other paediatric rheumatological conditions and provide evidence-based treatments for children affected by rheumatic diseases.

European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States.

PubMed

Qu, Liping; Zou, Wenjun; Wang, YiTao; Wang, Mei

2018-03-15

The European Union (EU) has created a regulatory framework for herbal medicinal products (HMPs) since the enforcement of Directive 2004/24/EC. Substantial achievements have been made, with 1719 traditional use marketing registrations (TURs) and 859 well-established use marketing authorizations (WEU-MAs) for HMPs granted by the end of 2016. Apparently, the European regulation model has worked out well and in that the essential feature is the use of EU herbal monographs into those granted WEU-MAs and TURs. A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies. A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected. The evaluation of applications by National Competent Authorities (NCAs) at a national level together with the assessment of EU monographs by the Committee on Herbal Medicinal Products (HMPC) at the European level constitute the European regulation framework for HMPs. As the scientific opinion about the safety and efficacy of HMPs from HMPC, the EU herbal monographs have been given a constitutional-based meaning to the TURs and WEU-MAs of HMPs and play a supportive function in the marketing procedure in Member States. The European framework has provided a powerful regulation model for harmonization of scientific assessment and facilitation of product marketing. For the pharmaceutical industries particularly those outside the EU, optimal use of the EU herbal monograph in their marketing procedure in Europe could be of great benefit. Furthermore, this model is well worth learning from for other countries and regions outside the EU to help the establishment of legislation in countries with strong traditional use of herbal remedies and contribute to the safe use of traditional herbal medicine. Copyright © 2018 Elsevier GmbH. All rights reserved.

Regulating Privacy and Biobanks in the Netherlands.

PubMed

Hendriks, Aart C; van Hellemondt, Rachèl E

2016-03-01

The Netherlands does not have any specific legislation pertaining to human biological materials and data collection by biobanks. Instead, these issues are governed by a patchwork of laws, codes of practices, and other ethical instruments, where special emphasis is given to the right to privacy and self-determination. While draft legislation for biobanking was scheduled to enter into force in 2007, as of mid-2015 such legislation was still under consideration, with the intent that it would focus particularly on individual self-determination, the interests of research, the use of bodily materials collected by biobanks for criminal law purposes, and dilemmas around results that are clinically relevant for biobank participants. Under the current framework, the amount of privacy protection afforded to data is linked to its level of identifiability. International sharing of personal data to non-EU/European Economic Area countries is allowed if these countries provide adequate protection. © 2016 American Society of Law, Medicine & Ethics.

Legislative aspects of the development of medical devices.

PubMed

Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil

2015-09-01

European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.

Towards a better pesticide policy for the European Union.

PubMed

Storck, Veronika; Karpouzas, Dimitrios G; Martin-Laurent, Fabrice

2017-01-01

This opinion article aims to foster the debate about pesticide legislation in the European Union (EU). Numerous formerly authorized and widely used pesticides are now banned in the EU because unexpected and unacceptable risks emerged after their initial introduction to the market. Throughout this time lapse, environmental quality and human health have been threatened by the use of these compounds. These hazards could have been prevented by a more responsive pesticide regulatory framework. This article provides detailed insights into the pros and cons of pesticides, and points out weaknesses of the current pesticide environmental risk assessment procedures. Possibilities for improving the robustness and reliability of the pesticide regulatory framework are discussed. Copyright © 2016 Elsevier B.V. All rights reserved.

Recent lung cancer mortality trends in Europe: effect of national smoke-free legislation strengthening.

PubMed

López-Campos, Jose L; Ruiz-Ramos, Miguel; Fernandez, Esteve; Soriano, Joan B

2018-07-01

The impact of smoke-free legislation within European Union (EU) countries on lung cancer mortality has not been evaluated to date. We aimed to determine lung cancer mortality trends in the EU-27 by sex, age, and calendar year for the period of 1994 and 2012, and relate them with changes in tobacco legislation at the national level. Deaths by Eurostat in each European country were analyzed, focusing on ICD-10 codes C33 and C34 from the years 1994 to 2012. Age-standardized mortality rates (ASR) were estimated separately for women and men in the EU-27 total and within country for each one of the years studied, and the significance of changing trends was estimated by joinpoint regression analysis, exploring lag times after initiation of smoke-free legislation in every country, if any. From 1994 to 2012, there were 4 681 877 deaths from lung cancer in Europe (3 491 607 in men and 1 190 180 in women) and a nearly linear decrease in mortality rates because of lung cancer in men from was observed1994 to 2012, mirrored in women by an upward trend, narrowing the sex gap during the study period from 5.1 in 1994 to 2.8 in 2012. Joinpoint regression analysis identified a number of trend changes over time, but it appears that they were unrelated to the implementation of smoke-free legislations. A few years after the introduction of smoke-free legislations across Europe, trends of lung cancer mortality trends have not changed.

Forensic DNA databases in Western Balkan region: retrospectives, perspectives, and initiatives

PubMed Central

Marjanović, Damir; Konjhodžić, Rijad; Butorac, Sara Sanela; Drobnič, Katja; Merkaš, Siniša; Lauc, Gordan; Primorac, Damir; Anđelinović, Šimun; Milosavljević, Mladen; Karan, Željko; Vidović, Stojko; Stojković, Oliver; Panić, Bojana; Vučetić Dragović, Anđelka; Kovačević, Sandra; Jakovski, Zlatko; Asplen, Chris; Primorac, Dragan

2011-01-01

The European Network of Forensic Science Institutes (ENFSI) recommended the establishment of forensic DNA databases and specific implementation and management legislations for all EU/ENFSI members. Therefore, forensic institutions from Bosnia and Herzegovina, Serbia, Montenegro, and Macedonia launched a wide set of activities to support these recommendations. To assess the current state, a regional expert team completed detailed screening and investigation of the existing forensic DNA data repositories and associated legislation in these countries. The scope also included relevant concurrent projects and a wide spectrum of different activities in relation to forensics DNA use. The state of forensic DNA analysis was also determined in the neighboring Slovenia and Croatia, which already have functional national DNA databases. There is a need for a ‘regional supplement’ to the current documentation and standards pertaining to forensic application of DNA databases, which should include regional-specific preliminary aims and recommendations. PMID:21674821

Forensic DNA databases in Western Balkan region: retrospectives, perspectives, and initiatives.

PubMed

Marjanović, Damir; Konjhodzić, Rijad; Butorac, Sara Sanela; Drobnic, Katja; Merkas, Sinisa; Lauc, Gordan; Primorac, Damir; Andjelinović, Simun; Milosavljević, Mladen; Karan, Zeljko; Vidović, Stojko; Stojković, Oliver; Panić, Bojana; Vucetić Dragović, Andjelka; Kovacević, Sandra; Jakovski, Zlatko; Asplen, Chris; Primorac, Dragan

2011-06-01

The European Network of Forensic Science Institutes (ENFSI) recommended the establishment of forensic DNA databases and specific implementation and management legislations for all EU/ENFSI members. Therefore, forensic institutions from Bosnia and Herzegovina, Serbia, Montenegro, and Macedonia launched a wide set of activities to support these recommendations. To assess the current state, a regional expert team completed detailed screening and investigation of the existing forensic DNA data repositories and associated legislation in these countries. The scope also included relevant concurrent projects and a wide spectrum of different activities in relation to forensics DNA use. The state of forensic DNA analysis was also determined in the neighboring Slovenia and Croatia, which already have functional national DNA databases. There is a need for a 'regional supplement' to the current documentation and standards pertaining to forensic application of DNA databases, which should include regional-specific preliminary aims and recommendations.

Pesticide authorization in the EU-environment unprotected?

PubMed

Stehle, Sebastian; Schulz, Ralf

2015-12-01

Pesticides constitute an integral part of high-intensity European agriculture. Prior to their authorization, a highly elaborated environmental risk assessment is mandatory according to EU pesticide legislation, i.e., Regulation (EC) No. 1107/2009. However, no field data-based evaluation of the risk assessment outcome, i.e., the regulatory acceptable concentrations (RACs), and therefore of the overall protectiveness of EU pesticide regulations exists. We conducted here a comprehensive meta-analysis using peer-reviewed literature on agricultural insecticide concentrations in EU surface waters and evaluated associated risks using the RACs derived from official European pesticide registration documents. As a result, 44.7 % of the 1566 cases of measured insecticide concentrations (MICs) in EU surface waters exceeded their respective RACs. It follows that current EU pesticide regulations do not protect the aquatic environment and that insecticides threaten aquatic biodiversity. RAC exceedances were significantly higher for insecticides authorized using conservative tier-I RACs and for more recently developed insecticide classes, i.e., pyrethroids. In addition, we identified higher risks, e.g., for smaller surface waters that are specifically considered in the regulatory risk assessment schemes. We illustrate the shortcomings of the EU regulatory risk assessment using two case studies that contextualize the respective risk assessment outcomes to field exposure. Overall, our meta-analysis challenges the field relevance and protectiveness of the regulatory environmental risk assessment conducted for pesticide authorization in the EU and indicates that critical revisions of related pesticide regulations and effective mitigation measures are urgently needed to substantially reduce the environmental risks arising from agricultural insecticide use.

Development of the EpiOcular(TM) eye irritation test for hazard identification and labelling of eye irritating chemicals in response to the requirements of the EU cosmetics directive and REACH legislation.

PubMed

Kaluzhny, Yulia; Kandárová, Helena; Hayden, Patrick; Kubilus, Joseph; d'Argembeau-Thornton, Laurence; Klausner, Mitchell

2011-09-01

The recently implemented 7th Amendment to the EU Cosmetics Directive and the EU REACH legislation have heightened the need for in vitro ocular test methods. To address this need, the EpiOcular(TM) eye irritation test (EpiOcular-EIT), which utilises the normal (non-transformed) human cell-based EpiOcular tissue model, has been developed. The EpiOcular-EIT prediction model is based on an initial training set of 39 liquid and 21 solid test substances and uses a single exposure period and a single cut-off in tissue viability, as determined by the MTT assay. A chemical is classified as an irritant (GHS Category 1 or 2), if the tissue viability is ≤ 60%, and as a non-irritant (GHS unclassified), if the viability is > 60%. EpiOcular-EIT results for the training set, along with results for an additional 52 substances, which included a range of alcohols, hydrocarbons, amines, esters, and ketones, discriminated between ocular irritants and non-irritants with 98.1% sensitivity, 72.9% specificity, and 84.8% accuracy. To ensure the long-term commercial viability of the assay, EpiOcular tissues produced by using three alternative cell culture inserts were evaluated in the EpiOcular-EIT with 94 chemicals. The assay results obtained with the initial insert and the three alternative inserts were very similar, as judged by correlation coefficients (r²) that ranged from 0.82 to 0.96. The EpiOcular-EIT was pre-validated in 2007/2008, and is currently involved in a formal, multi-laboratory validation study sponsored by the European Cosmetics Association (COLIPA) under the auspices of the European Centre for the Validation of Alternative Methods (ECVAM). The EpiOcular-EIT, together with EpiOcular's long history of reproducibility and proven utility for ultra-mildness testing, make EpiOcular a useful model for addressing current legislation related to animal use in the testing of potential ocular irritants. 2011 FRAME.

Teenage pregnancies in the European Union in the context of legislation and youth sexual and reproductive health services.

PubMed

Part, Kai; Moreau, Caroline; Donati, Serena; Gissler, Mika; Fronteira, Inês; Karro, Helle

2013-12-01

To study cross-country and regional variations and trends in reported teenage pregnancies in the context of legislation and youth sexual and reproductive health (SRH) services in Europe. Data were collected on teenage live births and induced abortions, abortion legislation and youth SRH services. Population-based statistics from the European Union (EU) member states. Fifteen- to nineteen-year-old female teenagers. Detailed statistical information for each member state about teenage live births, induced abortions, abortion legislation and youth SRH services were compiled relying on national and international data sources. The annual reported pregnancies per 1000 women aged 15-19 years. Teenage pregnancy rates have declined since 2001, although progress has been uneven across regions and countries. Eastern Europe has a higher average teenage pregnancy rate (41.7/1000) than Northern (30.7/1000), Western (18.2/1000) and Southern Europe (17.6/1000). While data on teenage live births are available across Europe, data on teenage abortions are unavailable or incomplete in more than one-third of EU countries. Reported teenage pregnancy rates are generally lower for countries where parental consent for abortion is not required, youth SRH services are available in all areas and contraceptives are subsidized for all minors, compared with countries where these conditions are not met. The collection of standardized teenage pregnancy statistics is critically needed in the EU. The remarkable variability in teenage pregnancy rates across the EU is likely to be explained, among other factors, by varying access to abortion and youth SRH services. © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Ozone concentrations and damage for realistic future European climate and air quality scenarios

NASA Astrophysics Data System (ADS)

Hendriks, Carlijn; Forsell, Nicklas; Kiesewetter, Gregor; Schaap, Martijn; Schöpp, Wolfgang

2016-11-01

Ground level ozone poses a significant threat to human health from air pollution in the European Union. While anthropogenic emissions of precursor substances (NOx, NMVOC, CH4) are regulated by EU air quality legislation and will decrease further in the future, the emissions of biogenic NMVOC (mainly isoprene) may increase significantly in the coming decades if short-rotation coppice plantations are expanded strongly to meet the increased biofuel demand resulting from the EU decarbonisation targets. This study investigates the competing effects of anticipated trends in land use change, anthropogenic ozone precursor emissions and climate change on European ground level ozone concentrations and related health and environmental impacts until 2050. The work is based on a consistent set of energy consumption scenarios that underlie current EU climate and air quality policy proposals: a current legislation case, and an ambitious decarbonisation case. The Greenhouse Gas-Air Pollution Interactions and Synergies (GAINS) integrated assessment model was used to calculate air pollutant emissions for these scenarios, while land use change because of bioenergy demand was calculated by the Global Biosphere Model (GLOBIOM). These datasets were fed into the chemistry transport model LOTOS-EUROS to calculate the impact on ground level ozone concentrations. Health damage because of high ground level ozone concentrations is projected to decline significantly towards 2030 and 2050 under current climate conditions for both energy scenarios. Damage to plants is also expected to decrease but to a smaller extent. The projected change in anthropogenic ozone precursor emissions is found to have a larger impact on ozone damage than land use change. The increasing effect of a warming climate (+2-5 °C across Europe in summer) on ozone concentrations and associated health damage, however, might be higher than the reduction achieved by cutting back European ozone precursor emissions. Global action to reduce air pollutant emissions is needed to make sure that ozone damage in Europe decreases towards the middle of this century.

Regulatory approaches to obesity prevention: A systematic overview of current laws addressing diet-related risk factors in the European Union and the United States.

PubMed

Sisnowski, Jana; Handsley, Elizabeth; Street, Jackie M

2015-06-01

High prevalence of overweight and obesity remains a significant international public health problem. Law has been identified as a tool for obesity prevention and selected high-profile measures have been reported. However, the nature and extent of enacted legislation internationally are unclear. This research provides an overview of regulatory approaches enacted in the United States, the European Union, and EU Member States since 2004. To this end, relevant databases of primary and secondary legislation were systematically searched to identify and explore laws addressing dietary risk factors for obesity. Across jurisdictions, current regulatory approaches to obesity prevention are limited in reach and scope. Target groups are rarely the general population, but instead sub-populations in government-supported settings. Consumer information provision is preferred over taxation and marketing restrictions other than the regulation of health and nutrition claims. In the EU in particular, product reformulation with industry consent has also emerged as a popular small-scale measure. While consistent and widespread use of law is lacking, governments have employed a range of regulatory measures in the name of obesity prevention, indicating that there is, in principle, political will. Results from this study may serve as a starting point for future research and policy development. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Search engine imaginary: Visions and values in the co-production of search technology and Europe.

PubMed

Mager, Astrid

2017-04-01

This article discusses the co-production of search technology and a European identity in the context of the EU data protection reform. The negotiations of the EU data protection legislation ran from 2012 until 2015 and resulted in a unified data protection legislation directly binding for all European member states. I employ a discourse analysis to examine EU policy documents and Austrian media materials related to the reform process. Using the concept 'sociotechnical imaginary', I show how a European imaginary of search engines is forming in the EU policy domain, how a European identity is constructed in the envisioned politics of control, and how national specificities contribute to the making and unmaking of a European identity. I discuss the roles that national technopolitical identities play in shaping both search technology and Europe, taking as an example Austria, a small country with a long history in data protection and a tradition of restrained technology politics.

Health law and policy in the European Union.

PubMed

Greer, Scott L; Hervey, Tamara K; Mackenbach, Johan P; McKee, Martin

2013-03-30

From its origins as six western European countries coming together to reduce trade barriers, the European Union (EU) has expanded, both geographically and in the scope of its actions, to become an important supranational body whose policies affect almost all aspects of the lives of its citizens. This influence extends to health and health services. The EU's formal responsibilities in health and health services are limited in scope, but, it has substantial indirect influence on them. In this paper, we describe the institutions of the EU, its legislative process, and the nature of European law as it affects free movement of the goods, people, and services that affect health or are necessary to deliver health care. We show how the influence of the EU goes far beyond the activities that are most visible to health professionals, such as research funding and public health programmes, and involves an extensive body of legislation that affects almost every aspect of health and health care.

Young people's perceptions of tobacco packaging: a comparison of EU Tobacco Products Directive & Ireland's Standardisation of Tobacco Act.

PubMed

Babineau, Kate; Clancy, Luke

2015-06-05

To measure young people's perceptions of tobacco packaging according to two current pieces of legislation: The EU Tobacco Products Directive (TPD) and Ireland's Public Health (Standardisation of Tobacco Products) Act. Within-subject experimental cross-sectional survey of a representative sample of secondary school students. School-based pen and paper survey. 27 secondary schools across Ireland, randomly stratified for size, geographic location, gender, religious affiliation and school-level socioeconomic status. Data were collected between March and May 2014. 1378 fifth year secondary school students aged 16-17 in Ireland. Young people's perceptions of attractiveness, health risk and smoker characteristics of packs according to EU and Irish branding and packaging guidelines. Packs with more branding elements were thought to be healthier than standardised packs for Silk Cut (χ(2)=158.58, p<0.001), Marlboro (χ(2)=113.65, p<0.001), and Benson and Hedges (χ(2)=137.95, p<0.001) brands. Generalized estimating equation binary regressions found that gender was a significant predictor of pack attractiveness for Silk Cut, with females being more likely to find the EU packs attractive (β=-0.45, p=0.007). Gender was a significant predictor for females with regards to the perceived popularity of the Silk Cut brand (β=-0.37, p=0.03). The removal of brand identifiers, including colour, font and embossing, reduces the perceived appeal of cigarette packs for young people across all three tested brands. Packs standardised according to Irish legislation are perceived as less attractive, less healthy and smoked by less popular people than packs which conform to the EU TPD 2014 guidelines. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The current status of orphan drug development in Europe and the US.

PubMed

Hall, Anthony K; Carlson, Marilyn R

2014-02-01

Orphan drug legislation has been introduced in a number of countries in order to stimulate the development of treatments for rare diseases by introducing commercial incentives for companies wishing to undertake that development. In order to navigate the maze of regulatory regulations and procedures so that companies can make proper use of the orphan drug incentives, specialist knowledge is required. This article will review the current status of orphan drug development in the EU and the US, explain the incentives and procedures, and touch on the role of patient organisations in the process.

Analysis of Turkish groundwater legislation and policy regarding international principles and conventions.

PubMed

Elvan, Osman Devrim; Turker, Y Ozhan

2014-01-01

Water resources have shaped the destinies of societies and affected settlement choice of civilizations for centuries. Demand for them is constantly increasing and this surge has become an important threat for water resources due to those excessive demands and variety of usage types; at the same time, balancing the protection and use of ground and surface waters has become more difficult. The progress in legal and corporate structures for water management has been too slow for a long time. In this study, principles of international conventions on groundwater are compared with the relevant Turkish groundwater legislation, which is in the process of harmonization with European Union (EU) acquis under the scope of Turkey's nomination for EU membership. The purpose of this study is to measure the compliance of Turkish legislation on groundwater with the relevant international principles and conventions, and also to analyze legal loopholes in Turkish legislation in accordance with the international principles and conventions to be determined.

Geographic Data as Personal Data in Four EU Member States

NASA Astrophysics Data System (ADS)

de Jong, A. J.; van Loenen, B.; Zevenbergen, J. A.

2016-06-01

The EU Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data aims at harmonising data protection legislation in the European Union. This should promote the free flow of products and services within the EU. This research found a wide variety of interpretations of the application of data protection legislation to geographic data. The variety was found among the different EU Member States, the different stakeholders and the different types of geographic data. In the Netherlands, the Data Protection Authority (DPA) states that panoramic images of streets are considered personal data. While Dutch case law judges that the data protection legislation does not apply if certain features are blurred and no link to an address is provided. The topographic datasets studied in the case studies do not contain personal data, according to the Dutch DPA, while the German DPA and the Belgian DPA judge that topographic maps of a large scale can contain personal data, and impose conditions on the processing of topographic maps. The UK DPA does consider this data outside of the scope of legal definition of personal data. The patchwork of differences in data protection legislation can be harmonised by using a traffic light model. This model focuses on the context in which the processing of the data takes place and has four categories of data: (1) sensitive personal data, (2) personal data, (3), data that can possibly lead to identification, and (4) non-personal data. For some geographic data, for example factual data that does not reveal sensitive information about a person, can be categorised in the third category giving room to opening up data under the INSPIRE Directive.

General sale of non-prescription medicinal products: Comparing legislation in two European countries.

PubMed

Lind, Johanna; Schafheutle, Ellen; Hägg, Annika Nordén; Sporrong, Sofia Kälvemark

2016-01-01

The number of non-prescription medicines (NPMs) available for self-medication is increasing within the European Union (EU). This can enhance the autonomy of individuals but is also connected with risks. Under an existing EU Directive, Sweden has only recently deregulated and made NPMs available in non-pharmacy outlets; The United Kingdom (UK) is a more established NPM market; both are guided by the same EU directives. The aim of this study was to compare specific requirements under the legislation, rationales and outcomes regarding the sale of NPMs through non-pharmacy outlets between Sweden and the UK. The main method was analysis of legislative text and policy documents, conducted in 2012. Both countries had specified medicines available to the public in non-pharmacy outlets, but with restrictions on different factors, e.g. placement and package size of the NPMs. The main rationales for legislation were quality and patient safety. NPMs for 51 ailments were available in the UK, compared to 35 in Sweden. Sweden had more extensive requirements, probably due to the market being more recently deregulated, while the UK represented a more mature market. There is a difference in the balance between confidence and control, as well as availability and safety when it comes to NPMs in non-pharmacy settings that needs to be further discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

Mutatis Mutandis? The Court of Justice of the European Union Rules that Member States May Be Allowed to Impose Non-Resident Student Quotas

ERIC Educational Resources Information Center

Observatory on Borderless Higher Education, 2010

2010-01-01

Earlier this month, the Court of Justice of the European Union (the Court), ruled that European Union (EU) member states can impose non-resident student quotas in certain circumstances. The Court, whose job is to ensure that all EU member states interpret and apply EU legislation in the same way, recently made the ruling in response to a…

Ethical evaluation of research proposals by ethics panels advising the European Commission.

PubMed

Kolar, Roman

2004-06-01

Ethical principles with regard to animal experimentation are referred to in European Union (EU) legislation and other official documents. Therefore, applications for funding of research under the EU's research programme may undergo an ethical review that is carried out by so-called ethics panels, consisting of experts chosen by the European Commission. The work of these panels differs substantially from that of other ethical committees, as they exist on the institutional, local, regional or national level. Their main purpose is not to decide whether a proposed research can be regarded legal, and therefore should be endorsed or licensed; instead, it is to help the Commission in prioritising its funding. The panels may examine other ethical aspects than those of animal experimentation or animal welfare alone, such as the use of human volunteers. This is reflected by the composition of the panels. Their decisions are normally based on consensus. Even though these decisions may refer to EU legislation, the criteria applied are not restricted to those provided by this legislation. Nevertheless, the various aspects of the Commission's ethical evaluation system (e.g. formal and practical basic conditions, information content of applications, type of decisions taken, lacking of any quality control) offers opportunities for improvement.

An Ever Closer Union . . . of Linguistic Diversity

ERIC Educational Resources Information Center

Tomozeiu, Daniel

2017-01-01

The analysis carried out between October 2014 and February 2015 by a team of researchers from the University of Westminster with support from colleagues from across the EU identified the linguistic communities across the 28 EU member states as recognized (or not) by the country's legislation and the linguistic rights of these communities in…

Regulatory and associated political issues with respect to Bt transgenic maize in the European union.

PubMed

Saeglitz, Christiane; Bartsch, Detlef

2003-06-01

Legislation at the national level in Europe as well as that developed by the European Union (EU) generally permits release and commercialization of genetically modified organisms (GMOs). However, only 10 plant/event combinations were registered as of 2002: three maize events (Bt176, Mon810, and Bt11), with the other seven divided among carnation (3), oil-seed rape (2), tobacco (1), and raddiccio (1). Of these, only one maize event (Bt176) has been registered as a legal variety, and this was in Spain, where 22,000ha have been planted annually since 1998. In this paper, we first provide an overview on the complexity of EU GMO legislation. Then we discuss the minor role that results of EU-funded biosafety research have had on governmental policy. Finally, we provide information about initiatives for post-commercialization monitoring plans of Bt maize in Europe. As a result of the slow progress to date, we conclude that commercialization of GMOs will be seriously delayed in the EU for the next several years.

Transnational Tobacco Company Interests in Smokeless Tobacco in Europe: Analysis of Internal Industry Documents and Contemporary Industry Materials

PubMed Central

Peeters, Silvy; Gilmore, Anna B.

2013-01-01

Background European Union (EU) legislation bans the sale of snus, a smokeless tobacco (SLT) which is considerably less harmful than smoking, in all EU countries other than Sweden. To inform the current review of this legislation, this paper aims to explore transnational tobacco company (TTC) interests in SLT and pure nicotine in Europe from the 1970s to the present, comparing them with TTCs' public claims of support for harm reduction. Methods and Results Internal tobacco industry documents (in total 416 documents dating from 1971 to 2009), obtained via searching the online Legacy Tobacco Documents Library, were analysed using a hermeneutic approach. This library comprises documents obtained via litigation in the US and does not include documents from Imperial Tobacco, Japan Tobacco International, or Swedish Match. To help overcome this limitation and provide more recent data, we triangulated our documentary findings with contemporary documentation including TTC investor presentations. The analysis demonstrates that British American Tobacco explored SLT opportunities in Europe from 1971 driven by regulatory threats and health concerns, both likely to impact cigarette sales negatively, and the potential to create a new form of tobacco use among those no longer interested in taking up smoking. Young people were a key target. TTCs did not, however, make SLT investments until 2002, a time when EU cigarette volumes started declining, smoke-free legislation was being introduced, and public health became interested in harm reduction. All TTCs have now invested in snus (and recently in pure nicotine), yet both early and recent snus test markets appear to have failed, and little evidence was found in TTCs' corporate materials that snus is central to their business strategy. Conclusions There is clear evidence that BAT's early interest in introducing SLT in Europe was based on the potential for creating an alternative form of tobacco use in light of declining cigarette sales and social restrictions on smoking, with young people a key target. We conclude that by investing in snus, and recently nicotine, TTCs have eliminated competition between cigarettes and lower-risk products, thus helping maintain the current market balance in favour of (highly profitable) cigarettes while ensuring TTCs' long-term future should cigarette sales decline further and profit margins be eroded. Please see later in the article for the Editors' Summary PMID:24058299

Transnational tobacco company interests in smokeless tobacco in Europe: analysis of internal industry documents and contemporary industry materials.

PubMed

Peeters, Silvy; Gilmore, Anna B

2013-01-01

European Union (EU) legislation bans the sale of snus, a smokeless tobacco (SLT) which is considerably less harmful than smoking, in all EU countries other than Sweden. To inform the current review of this legislation, this paper aims to explore transnational tobacco company (TTC) interests in SLT and pure nicotine in Europe from the 1970s to the present, comparing them with TTCs' public claims of support for harm reduction. Internal tobacco industry documents (in total 416 documents dating from 1971 to 2009), obtained via searching the online Legacy Tobacco Documents Library, were analysed using a hermeneutic approach. This library comprises documents obtained via litigation in the US and does not include documents from Imperial Tobacco, Japan Tobacco International, or Swedish Match. To help overcome this limitation and provide more recent data, we triangulated our documentary findings with contemporary documentation including TTC investor presentations. The analysis demonstrates that British American Tobacco explored SLT opportunities in Europe from 1971 driven by regulatory threats and health concerns, both likely to impact cigarette sales negatively, and the potential to create a new form of tobacco use among those no longer interested in taking up smoking. Young people were a key target. TTCs did not, however, make SLT investments until 2002, a time when EU cigarette volumes started declining, smoke-free legislation was being introduced, and public health became interested in harm reduction. All TTCs have now invested in snus (and recently in pure nicotine), yet both early and recent snus test markets appear to have failed, and little evidence was found in TTCs' corporate materials that snus is central to their business strategy. There is clear evidence that BAT's early interest in introducing SLT in Europe was based on the potential for creating an alternative form of tobacco use in light of declining cigarette sales and social restrictions on smoking, with young people a key target. We conclude that by investing in snus, and recently nicotine, TTCs have eliminated competition between cigarettes and lower-risk products, thus helping maintain the current market balance in favour of (highly profitable) cigarettes while ensuring TTCs' long-term future should cigarette sales decline further and profit margins be eroded. Please see later in the article for the Editors' Summary.

Occupational health legislation and practices related to seafarers on passenger ships focused on communicable diseases: results from a European cross-sectional study (EU SHIPSAN PROJECT)

PubMed Central

2010-01-01

Background Seafarers play an important role in the transmission of communicable diseases. The aim of the present study is to draw information and identify possible gaps on occupational health practices related to seafarers sailing on ships within the European Union Member States (EU MS) with focus on communicable diseases. Methods A structured questionnaire was sent to competent authorities from 21 EU MS. The questionnaire included questions about occupational health policies, medical certification of seafarers, communicable diseases reporting and relevant legislation. Descriptive analysis of the data was conducted by the use of Epi Info software: EU MS were categorized in four priority groups (A, B, C, D) based on: number of passenger ships visits, volume of passengers, and number of ports in each country. Moreover, EU MS were categorized to old and new, based on the date of entry in the EU. Results All 21 countries with relevant competent authorities responded to the questionnaire. The existence of specific national legislation/regulation/guidelines related to vaccination of seafarers was reported by three out of the 21 (14%) responding authorities. Surveillance data of communicable diseases related to seafarers are collected and analyzed by 4 (19%) authorities. Five out of 21 of the responding countries (24%) reported that tuberculin test result is required for the issuance of seafarer's medical certificate while a great variety of medical examination is required for the issuance of this certificate among countries. Gaps on occupational health services focused on communicable diseases related to maritime occupation have been reported by 33% of the responding countries. Responding authorities from Group A and B had the highest percentage of reported gaps followed by groups C and D. Old MS reported a higher frequency regarding gaps on occupational health services in comparison to new MS. Conclusion Our results revealed heterogeneity regarding occupational health of maritime employees in EU MS. This work provides some evidence that further work at international and European level could be considered, in order to explore the potential for harmonized initiatives regarding occupational health of seafarers. PMID:20181140

The effect of somatic cell count data adjustment and interpretation, as outlined in European Union legislation, on herd eligibility to supply raw milk for processing of dairy products.

PubMed

More, S J; Clegg, T A; Lynch, P J; O'Grady, L

2013-06-01

Somatic cell count (SCC) limits are a key component of national and international regulation for milk quality. As yet, very limited work has been published on SCC regulatory standards, including on the effect of different approaches to SCC data adjustment and interpretation. This study examines the effect of SCC data adjustment and interpretation, as outlined in current European Union (EU) legislation, on herd eligibility to supply raw milk for processing of dairy products for human consumption, using Irish data for illustration. The study used Irish milk-recording data as a proxy for bulk tank SCC (BTSCC) data, to calculate an unadjusted monthly SCC value for each herd during each month of participation. Subsequently, 4 data adjustments were applied, as outlined in EU and national legislation: seasonal adjustment; 3-mo rolling geometric average, without accounting for a break in the supply; 3-mo rolling geometric average, after accounting for a break in the supply; and seasonal adjustment and 3-mo rolling geometric average combined, after accounting for a break in the supply. Analyses were conducted to examine the effect, during the period from 2004 to 2010, of data adjustment on the percentage of herds with herd SCC >400,000 cells/mL. In all, 4 interpretation scenarios, incorporating different data adjustment combinations, were used to estimate herd eligibility (compliant, under warning, or suspended, as defined by legislation) to supply raw milk for processing. The 4 methods of data adjustment each led to a sizable reduction (6.7, 5.0, 5.3, and 11.1 percentage points, respectively, compared with the unadjusted data) in the percentage of herds exceeding a herd SCC of 400,000 cells/mL. Herd eligibility varied by interpretation scenarios, in particular those incorporating seasonal adjustment. The study provides new perspectives on the effect of data adjustment on herd SCC and of interpretation scenarios on herd eligibility. The results provide an illustrative, rather than definitive, picture of this effect, as national authorities use BTSCC data when determining herd eligibility, whereas this study was conducted using milk-recording data as a proxy. Some aspects of the primary EU legislation are unclear, which may lead to differences in interpretation and application. The potential impact of data adjustment and milk purchaser pricing on farm-level mastitis control in Ireland is considered. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Identification, assessment and management of "endocrine disruptors" in wildlife in the EU substance legislation--discussion paper from the German Federal Environment Agency (UBA).

PubMed

Frische, Tobias; Bachmann, Jean; Frein, Daniel; Juffernholz, Tanja; Kehrer, Anja; Klein, Anita; Maack, Gerd; Stock, Frauke; Stolzenberg, Hans-Christian; Thierbach, Claudia; Walter-Rohde, Susanne

2013-12-16

A discussion paper was developed by a panel of experts of the German Federal Environment Agency (UBA) contributing to the on-going debate on the identification, assessment and management of endocrine disruptors with a view to protect wildlife according to the EU substance legislation (plant protection products, biocides, industrial chemicals). Based on a critical synthesis of the state-of-the-art regarding regulatory requirements, testing methods, assessment schemes, decision-making criteria and risk management options, we advise an appropriate and consistent implementation of this important subject into existing chemicals legislation in Europe. Our proposal for a balanced risk management of endocrine disruptors essentially advocates transparent regulatory decision making based on a scientifically robust weight of evidence approach and an adequate risk management consistent across different legislations. With respect to the latter, a more explicit consideration of the principle of proportionality of regulatory decision making and socio-economic benefits in the on-going debate is further encouraged. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Regulation of non-relevant metabolites of plant protection products in drinking and groundwater in the EU: Current status and way forward.

PubMed

Laabs, V; Leake, C; Botham, P; Melching-Kollmuß, S

2015-10-01

Non-relevant metabolites are defined in the EU regulation for plant protection product authorization and a detailed definition of non-relevant metabolites is given in an EU Commission DG Sanco (now DG SANTE - Health and Food Safety) guidance document. However, in water legislation at EU and member state level non-relevant metabolites of pesticides are either not specifically regulated or diverse threshold values are applied. Based on their inherent properties, non-relevant metabolites should be regulated based on substance-specific and toxicity-based limit values in drinking and groundwater like other anthropogenic chemicals. Yet, if a general limit value for non-relevant metabolites in drinking and groundwater is favored, an application of a Threshold of Toxicological Concern (TTC) concept for Cramer class III compounds leads to a threshold value of 4.5 μg L(-1). This general value is exemplarily shown to be protective for non-relevant metabolites, based on individual drinking water limit values derived for a set of 56 non-relevant metabolites. A consistent definition of non-relevant metabolites of plant protection products, as well as their uniform regulation in drinking and groundwater in the EU, is important to achieve legal clarity for all stakeholders and to establish planning security for development of plant protection products for the European market. Copyright © 2015 Elsevier Inc. All rights reserved.

Inclusive Education in Progress: Policy Evolution in Four European Countries

ERIC Educational Resources Information Center

Smyth, Fiona; Shevlin, Michael; Buchner, Tobias; Biewer, Gottfried; Flynn, Paula; Latimier, Camille; Šiška, Jan; Toboso-Martín, Mario; Rodríguez Díaz, Susana; Ferreira, Miguel A. V.

2014-01-01

This paper seeks to compare the evolution of inclusive education policy in the four countries of an EU-funded research project (QualiTYDES) operating under the shared policy environment of the UN, EU and European Commission. A shared policy cannot of course be assumed to result in common legislative or provisional outcomes at national level. The…

Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems.

PubMed

Pirnay, Jean-Paul; Vanderkelen, Alain; De Vos, Daniel; Draye, Jean-Pierre; Rose, Thomas; Ceulemans, Carl; Ectors, Nadine; Huys, Isabelle; Jennes, Serge; Verbeken, Gilbert

2013-12-01

The transplantation of conventional human cell and tissue grafts, such as heart valve replacements and skin for severely burnt patients, has saved many lives over the last decades. The late eighties saw the emergence of tissue engineering with the focus on the development of biological substitutes that restore or improve tissue function. In the nineties, at the height of the tissue engineering hype, industry incited policymakers to create a European regulatory environment, which would facilitate the emergence of a strong single market for tissue engineered products and their starting materials (human cells and tissues). In this paper we analyze the elaboration process of this new European Union (EU) human cell and tissue product regulatory regime-i.e. the EU Cell and Tissue Directives (EUCTDs) and the Advanced Therapy Medicinal Product (ATMP) Regulation and evaluate its impact on Member States' health care systems. We demonstrate that the successful lobbying on key areas of regulatory and policy processes by industry, in congruence with Europe's risk aversion and urge to promote growth and jobs, led to excessively business oriented legislation. Expensive industry oriented requirements were introduced and contentious social and ethical issues were excluded. We found indications that this new EU safety and health legislation will adversely impact Member States' health care systems; since 30 December 2012 (the end of the ATMP transitional period) there is a clear threat to the sustainability of some lifesaving and established ATMPs that were provided by public health institutions and small and medium-sized enterprises under the frame of the EUCTDs. In the light of the current economic crisis it is not clear how social security systems will cope with the inflation of costs associated with this new regulatory regime and how priorities will be set with regard to reimbursement decisions. We argue that the ATMP Regulation should urgently be revised to focus on delivering affordable therapies to all who are in need of them and this without necessarily going to the market. The most rapid and elegant way to achieve this would be for the European Commission to publish an interpretative document on "placing on the market of ATMPs," which keeps tailor-made and niche ATMPs outside of the scope of the medicinal product regulation.

Environmental contaminants of emerging concern in seafood--European database on contaminant levels.

PubMed

Vandermeersch, Griet; Lourenço, Helena Maria; Alvarez-Muñoz, Diana; Cunha, Sara; Diogène, Jorge; Cano-Sancho, German; Sloth, Jens J; Kwadijk, Christiaan; Barcelo, Damia; Allegaert, Wim; Bekaert, Karen; Fernandes, José Oliveira; Marques, Antonio; Robbens, Johan

2015-11-01

Marine pollution gives rise to concern not only about the environment itself but also about the impact on food safety and consequently on public health. European authorities and consumers have therefore become increasingly worried about the transfer of contaminants from the marine environment to seafood. So-called "contaminants of emerging concern" are chemical substances for which no maximum levels have been laid down in EU legislation, or substances for which maximum levels have been provided but which require revision. Adequate information on their presence in seafood is often lacking and thus potential risks cannot be excluded. Assessment of food safety issues related to these contaminants has thus become urgent and imperative. A database (www.ecsafeseafooddbase.eu), containing available information on the levels of contaminants of emerging concern in seafood and providing the most recent data to scientists and regulatory authorities, was developed. The present paper reviews a selection of contaminants of emerging concern in seafood including toxic elements, endocrine disruptors, brominated flame retardants, pharmaceuticals and personal care products, polycyclic aromatic hydrocarbons and derivatives, microplastics and marine toxins. Current status on the knowledge of human exposure, toxicity and legislation are briefly presented and the outcome from scientific publications reporting on the levels of these compounds in seafood is presented and discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

Analysis of good practices, barriers and drivers for ELTs pyrolysis industrial application.

PubMed

Zabaniotou, A; Antoniou, N; Bruton, G

2014-11-01

Boosting of eco-innovative solutions for End of Life Tyres (ELTs) management, under the principles of the EU Resource Efficiency Roadmap and the Waste Framework Directive, can not only diminish the environmental hazards and the consequent societal cost, but also result to the establishment of a novel perception regarding ELTs; thus, a valuable stock of resources that can be exploited. Despite the extensive scientific research of the previous years on ELTs depolymerisation via pyrolysis highlighting its eco-innovative characteristics, the use of pyrolysis to process scrap tyres has not yet achieved a broad commercial success, with economic viability and product standardization to constitute the primary impediments. More specifically, pyrolysis was not applied to an extensive industrial scale so far, due to deficient market analysis, legislative barriers, economic instability and sometimes public acceptance. All the above issues are addressed by the present study. Modifications on current EU legislation can prevent or reduce delays or derailment of efforts on pyrolysis, through its differentiation from incineration. The attainment of economic viability could be realized through the valorization of the pyrolytic char towards activated carbon production for environmental depollution applications; needless to say, the penetration on niche and well-organised markets is more than essential. Copyright © 2014 Elsevier Ltd. All rights reserved.

Future trends in soil cadmium concentration under current cadmium fluxes to European agricultural soils.

PubMed

Six, L; Smolders, E

2014-07-01

The gradual increase of soil cadmium concentrations in European soils during the 20th century has prompted environmental legislation to limit soil cadmium (Cd) accumulation. Mass balances (input-output) reflecting the period 1980-1995 predicted larger Cd inputs via phosphate (P) fertilizers and atmospheric deposition than outputs via crop uptake and leaching. This study updates the Cd mass balance for the agricultural top soils of EU-27+Norway (EU-27+1). Over the past 15 years, the use of P fertilizers in the EU-27+1 has decreased by 40%. The current mean atmospheric deposition of Cd in EU is 0.35 g Cd ha(-1) yr(-1), this is strikingly smaller than values used in the previous EU mass balances (~3 g Cd ha(-1) yr(-1)). Leaching of Cd was estimated with most recent data of soil solution Cd concentrations in 151 soils, which cover the range of European soil properties. No significant time trends were found in the data of net applications of Cd via manure, compost, sludge and lime, all being small sources of Cd at a large scale. Modelling of the future long-term changes in soil Cd concentrations in agricultural top soils under cereal or potato culture predicts soil Cd concentrations to decrease by 15% over the next 100 years in an average scenario, with decreasing trends in some scenarios being more prevalent than increasing trends in other scenarios. These Cd balances have reverted from the general positive balances estimated 10 or more years ago. Uncertainty analysis suggests that leaching is the most uncertain relative to other fluxes. Copyright © 2014 Elsevier B.V. All rights reserved.

A VIEW OF TURKEY AND EUROPEAN RELATIONS FROM THE PERSPECTIVE OF MEDICAL LEGISLATION: AN ASSESMENT OF STATE OF PLAY

PubMed Central

Ekmekçi, Perihan Elif; Arda, Berna

2015-01-01

The aim of this paper is to reflect the situation of health legislation alignment in Turkey in its accession process to the European Union and Customs Union Agreement, and to discuss the the EU’s health priorities of in parallel with the Turkish ones. The health legislation alignment processes consist of three titles which are: European Union alignment process, the harmonization done in the framework of membership to Council of Europe, and the obligations under the Customs Union Agreement. Significant human resources are required for the adoption of the legislations which make ethically imperative the discussion of whether there is a harmony among the priorities of both parities. Unless this harmony and paralellisim is shown, the human resources appointed for the adoption of health legislation process would not prove their efficiency and effectiveness. In this article, the Customs Union and formal negotiations for full EU membership are included in the phrase “the alignment process to European Union”. Council Decisions 1/95 and 2/97 ground on the obligations provided by the Customs Union Agreement. The reference document used to discuss the formal negotiation process for full membership to European Union is the Turkish National Program for the Adoption of the EU Acquis 2008–2013. The legislative obligations of Turkey arising from its membership of the Council of Europe, which has significant contributions to the medical legislation especially in the field of medical ethics, are also included in this article. PMID:26269696

Pharmacy Practice and Education in the Czech Republic.

PubMed

Nachtigal, Petr; Šimůnek, Tomáš; Atkinson, Jeffrey

2017-10-09

The PHARMINE ("Pharmacy Education in Europe") project studied the organisation of pharmacy education, practice and legislation in the European Union (EU) with the objectives of evaluating to what degree harmonisation had taken place with the EU, and producing documents on each individual EU member state. Part of this work was in the form of a survey of pharmacy education, practice, and legislation in the various member states. We will publish the individual member state surveys as reference documents. This paper presents the results of the PHARMINE survey on pharmacy education, training, and practice in the Czech Republic. Czech community pharmacies sell and provide advice on Rx and Over-the-counter (OTC) medicines; they also provide diagnostic services (e.g., blood pressure measurement). Pharmacists ( lékárník in Czech) study for five years and graduate with a Magister (Mgr., equivalent to M.Pharm.) degree. The Mgr. diploma is the only requirement for registration as a pharmacist. Pharmacists can own and manage community pharmacies, or work as responsible pharmacists in pharmacies. All practising pharmacists must be registered with the Czech Chamber of Pharmacists. The ownership of a community pharmacy is not restricted to members of the pharmacy profession; the majority of pharmacies are organised into various pharmacy chains. There are two universities providing higher education in pharmacy in the Czech Republic: the Faculty of Pharmacy in Hradec Kralove, Charles University, which was established in 1969, and the Faculty of Pharmacy of the University of Veterinary and Pharmaceutical Sciences in Brno, which was established in 1991. The pharmacy curriculum is organized as a seamless, fully integrated, five-year master degree course. There is a six-month traineeship supervised by the university, which usually takes place during the fifth year. Thus, the pharmacy curriculum is organised in accordance with the EU directive on sectoral professions that lays down the imperatives for pharmacy education, training, and practice in the various member states of the EU. Currently, no specialisation courses are available at the university level. Specialisation is organised in the form of postgraduate, continuing professional development by the Czech Chamber of Pharmacists, and delivered by the Institute of Postgraduate Education for Health Professions.

Pharmacy Practice and Education in the Czech Republic †

PubMed Central

Nachtigal, Petr; Šimůnek, Tomáš; Atkinson, Jeffrey

2017-01-01

The PHARMINE (“Pharmacy Education in Europe”) project studied the organisation of pharmacy education, practice and legislation in the European Union (EU) with the objectives of evaluating to what degree harmonisation had taken place with the EU, and producing documents on each individual EU member state. Part of this work was in the form of a survey of pharmacy education, practice, and legislation in the various member states. We will publish the individual member state surveys as reference documents. This paper presents the results of the PHARMINE survey on pharmacy education, training, and practice in the Czech Republic. Czech community pharmacies sell and provide advice on Rx and Over-the-counter (OTC) medicines; they also provide diagnostic services (e.g., blood pressure measurement). Pharmacists (lékárník in Czech) study for five years and graduate with a Magister (Mgr., equivalent to M.Pharm.) degree. The Mgr. diploma is the only requirement for registration as a pharmacist. Pharmacists can own and manage community pharmacies, or work as responsible pharmacists in pharmacies. All practising pharmacists must be registered with the Czech Chamber of Pharmacists. The ownership of a community pharmacy is not restricted to members of the pharmacy profession; the majority of pharmacies are organised into various pharmacy chains. There are two universities providing higher education in pharmacy in the Czech Republic: the Faculty of Pharmacy in Hradec Kralove, Charles University, which was established in 1969, and the Faculty of Pharmacy of the University of Veterinary and Pharmaceutical Sciences in Brno, which was established in 1991. The pharmacy curriculum is organized as a seamless, fully integrated, five-year master degree course. There is a six-month traineeship supervised by the university, which usually takes place during the fifth year. Thus, the pharmacy curriculum is organised in accordance with the EU directive on sectoral professions that lays down the imperatives for pharmacy education, training, and practice in the various member states of the EU. Currently, no specialisation courses are available at the university level. Specialisation is organised in the form of postgraduate, continuing professional development by the Czech Chamber of Pharmacists, and delivered by the Institute of Postgraduate Education for Health Professions. PMID:28991203

Reducing the land use of EU pork production: where there’s swill, there’s a way

PubMed Central

zu Ermgassen, Erasmus K.H.J.; Phalan, Ben; Green, Rhys E.; Balmford, Andrew

2016-01-01

Livestock production occupies approximately 75% of agricultural land, consumes 35% of the world’s grain, and produces 14.5% of anthropogenic greenhouse gas emissions. With demand for meat and dairy products forecast to increase 60% by 2050, there is a pressing need to reduce the footprint of livestock farming. Food wastes have a long history as a source of environmentally benign animal feed, but their inclusion in feed is currently banned in the EU because of disease control concerns. A number of East Asian states have in the last 20 years, however, introduced regulated, centralised systems for safely recycling food wastes into animal feed. This study quantifies the land use savings that could be realised by changing EU legislation to promote the use of food wastes as animal feed and reviews the policy, public, and industry barriers to the use of food waste as feed. Our results suggest that the application of existing technologies could reduce the land use of EU pork (20% of world production) by one fifth, potentially saving 1.8 million hectares of agricultural land. While swill presents a low-cost, low-impact animal feed, widespread adoption would require efforts to address consumer and farmer concerns over food safety and disease control. PMID:26949285

Reducing the land use of EU pork production: where there's swill, there's a way.

PubMed

Zu Ermgassen, Erasmus K H J; Phalan, Ben; Green, Rhys E; Balmford, Andrew

2016-01-01

Livestock production occupies approximately 75% of agricultural land, consumes 35% of the world's grain, and produces 14.5% of anthropogenic greenhouse gas emissions. With demand for meat and dairy products forecast to increase 60% by 2050, there is a pressing need to reduce the footprint of livestock farming. Food wastes have a long history as a source of environmentally benign animal feed, but their inclusion in feed is currently banned in the EU because of disease control concerns. A number of East Asian states have in the last 20 years, however, introduced regulated, centralised systems for safely recycling food wastes into animal feed. This study quantifies the land use savings that could be realised by changing EU legislation to promote the use of food wastes as animal feed and reviews the policy, public, and industry barriers to the use of food waste as feed. Our results suggest that the application of existing technologies could reduce the land use of EU pork (20% of world production) by one fifth, potentially saving 1.8 million hectares of agricultural land. While swill presents a low-cost, low-impact animal feed, widespread adoption would require efforts to address consumer and farmer concerns over food safety and disease control.

Non-European traditional herbal medicines in Europe: a community herbal monograph perspective.

PubMed

Qu, Liping; Zou, Wenjun; Zhou, Zhenxiang; Zhang, Tingmo; Greef, JanVander; Wang, Mei

2014-10-28

The European Directive 2004/24/EC introducing a simplified registration procedure for traditional herbal medicinal products, plays an important role in harmonising the current legislation framework for all herbal medicinal products in the European Union (EU). Although substantial achievements have been made under the new scheme, only a limited number of herbal medicinal products from non-European traditions commonly used in Europe have been registered. Therefore, identification of the obstacles, and determination of appropriate means to overcome the major challenges in the registration of non-European traditional herbal medicinal products are of critical importance for the EU herbal medicinal product market. The primary aims of this study were to understand the key issues and obstacles to registration of non-European traditional herbal medicinal products within the EU. The findings may identify the need for more attention on the Community herbal monographs elaborated by the Herbal Medicinal Products Committee (HMPC), as well as further evidence based scientific research on non-European herbal substances/preparations by the scientific community. A systematic evaluation of the herbal substances and preparations included in Community herbal monographs and public statements has been carried out. The focus was herbal substances and preparations derived from non-European traditions. Of the 109 adopted Community herbal monographs, 10 are herbal substances used in Chinese traditional medicine. Where the HMPC issued a public statement because it was unable to elaborate a monograph more than half-involved herbal substances/preparations from non-European traditions. The main reasons herbal substances/preparations from non-European traditions were not accepted for inclusion in the Community herbal monographs have been identified as due to unfulfilled requirements of Directive 2004/24/EC. The most common reasons were the lack of evidence to demonstrate a 15-year minimum medicinal use period in the EU and evidence of absence of health risk as required by Article 16a (1) (d), and Article 16a (1) (e). Under the current EU legislation, the requirement to demonstrate 15-year minimum medicinal use in the EU is a major obstacle to the registration of non-European traditional herbal medicinal products. Access to scientific data to support the product safety profile may be a possible solution to overcome the hurdle presented by the 15-year minimum medicinal use period. Furthermore, the Community herbal monographs play an important role in the registration process. Therefore, making full use of existing Community herbal monographs, and promoting scientific research and subsequent development of additional monographs for herbal substances and preparations, and combinations thereof from non-European traditions would be of benefit to herbal medicinal product registration from non-European traditions. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements.

PubMed

Pastorino, Boris; de Lamballerie, Xavier; Charrel, Rémi

2017-01-01

Even if European Union (EU) Member States are obliged to implement EU Directives 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work , national biosafety regulations and practices varied from country to country. In fact, EU legislation on biological agents and genetically modified microorganisms is often not specific enough to ensure harmonization leading to difficulties in implementation for most laboratories. In the same way, biosecurity is a relatively new concept and a few EU Member States are known to have introduced national laboratory biosecurity legislation. In France, recent regulations have reinforced biosafety/biosecurity in containment level 3 (CL-3) laboratories but they concern a specific list of pathogens with no correlation in other European Members States. The objective of this review was to summarize European biosafety/biosecurity measures concerning CL-3 facilities focusing on French specificities. Essential requirements needed to preserve efficient biosafety measures when manipulating risk group 3 biological agents are highlighted. In addition, International, European and French standards related to containment laboratory planning, operation or biosafety equipment are described to clarify optimal biosafety and biosecurity requirements.

Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements

PubMed Central

Pastorino, Boris; de Lamballerie, Xavier; Charrel, Rémi

2017-01-01

Even if European Union (EU) Member States are obliged to implement EU Directives 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, national biosafety regulations and practices varied from country to country. In fact, EU legislation on biological agents and genetically modified microorganisms is often not specific enough to ensure harmonization leading to difficulties in implementation for most laboratories. In the same way, biosecurity is a relatively new concept and a few EU Member States are known to have introduced national laboratory biosecurity legislation. In France, recent regulations have reinforced biosafety/biosecurity in containment level 3 (CL-3) laboratories but they concern a specific list of pathogens with no correlation in other European Members States. The objective of this review was to summarize European biosafety/biosecurity measures concerning CL-3 facilities focusing on French specificities. Essential requirements needed to preserve efficient biosafety measures when manipulating risk group 3 biological agents are highlighted. In addition, International, European and French standards related to containment laboratory planning, operation or biosafety equipment are described to clarify optimal biosafety and biosecurity requirements. PMID:28620600

New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation.

PubMed

Martinac, Adrijana Ilić; Tomić, Sinisa; Simicić, Mirna

2010-09-01

Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

Legislative regulation and ethical governance of medical research in different European Union countries.

PubMed

Veerus, Piret; Lexchin, Joel; Hemminki, Elina

2014-06-01

To obtain information about the similarities and differences in regulating different types of medical research in the European Union (EU). Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010. In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees (RECs) in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries. There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Partnerships for affordable and equitable disaster insurance

NASA Astrophysics Data System (ADS)

Mysiak, J.; Pérez-Blanco, C. D.

2015-08-01

Extreme events are becoming more frequent and intense, inflating the economic damages and social hardship set-off by natural catastrophes. Amidst budgetary cuts, there is a growing concern on societies' ability to design solvent disaster recovery strategies, while addressing equity and affordability concerns. The participation of private sector along with public one through Public-Private Partnerships (PPPs) has gained on importance as a means to address these seemingly conflicting objectives through the provision of (catastrophic) natural hazard insurance. This is the case of many OECD countries, notably some EU Member States such as the United Kingdom and Spain. The EU legislator has adapted to this new scenario and recently produced major reforms in the legislation and regulation that govern the framework in which PPPs for (catastrophic) natural hazard insurance develop. This paper has a dual objective: (1) review the complex legal background that rules the provision of insurance against natural catastrophes in the EU after these major reforms, (2) assess the implications of the reforms and offer concise Policy Guiding Principles.

Partnerships for disaster risk insurance in the EU

NASA Astrophysics Data System (ADS)

Mysiak, Jaroslav; Dionisio Pérez-Blanco, C.

2016-11-01

With increasing costs inflicted by natural hazard perils, and amidst state budget cuts, concerns are mounting about the capacity of governments to design sustainable, equitable and affordable risk management schemes. The participation of the private sector along with the public one through public-private partnerships (PPPs) has gained importance as a means of providing catastrophic natural hazard insurance to address these seemingly conflicting objectives. In 2013 the European Commission launched a wide-ranging consultation about what EU action could be appropriate to improve the performance of insurance markets. Simultaneously, the EU legislator instigated major reforms in the legislation and regulations that pertain to how PPPs are designed or operate. This paper has a dual objective: first, we review and summarize the manifold legal background that influences the provision of insurance against natural catastrophes. Second, we examine how PPPs designed for sharing and transferring risk operate within the European regulatory constraints, illustrated using the example of the UK Flood Reinsurance Scheme (Flood RE) between the state and the Association of British Insurers.

Detection and traceability of genetically modified organisms in the food production chain.

PubMed

Miraglia, M; Berdal, K G; Brera, C; Corbisier, P; Holst-Jensen, A; Kok, E J; Marvin, H J P; Schimmel, H; Rentsch, J; van Rie, J P P F; Zagon, J

2004-07-01

Both labelling and traceability of genetically modified organisms are current issues that are considered in trade and regulation. Currently, labelling of genetically modified foods containing detectable transgenic material is required by EU legislation. A proposed package of legislation would extend this labelling to foods without any traces of transgenics. These new legislations would also impose labelling and a traceability system based on documentation throughout the food and feed manufacture system. The regulatory issues of risk analysis and labelling are currently harmonised by Codex Alimentarius. The implementation and maintenance of the regulations necessitates sampling protocols and analytical methodologies that allow for accurate determination of the content of genetically modified organisms within a food and feed sample. Current methodologies for the analysis of genetically modified organisms are focused on either one of two targets, the transgenic DNA inserted- or the novel protein(s) expressed- in a genetically modified product. For most DNA-based detection methods, the polymerase chain reaction is employed. Items that need consideration in the use of DNA-based detection methods include the specificity, sensitivity, matrix effects, internal reference DNA, availability of external reference materials, hemizygosity versus homozygosity, extrachromosomal DNA, and international harmonisation. For most protein-based methods, enzyme-linked immunosorbent assays with antibodies binding the novel protein are employed. Consideration should be given to the selection of the antigen bound by the antibody, accuracy, validation, and matrix effects. Currently, validation of detection methods for analysis of genetically modified organisms is taking place. In addition, new methodologies are developed, including the use of microarrays, mass spectrometry, and surface plasmon resonance. Challenges for GMO detection include the detection of transgenic material in materials with varying chromosome numbers. The existing and proposed regulatory EU requirements for traceability of genetically modified products fit within a broader tendency towards traceability of foods in general and, commercially, towards products that can be distinguished from each other. Traceability systems document the history of a product and may serve the purpose of both marketing and health protection. In this framework, segregation and identity preservation systems allow for the separation of genetically modified and non-modified products from "farm to fork". Implementation of these systems comes with specific technical requirements for each particular step of the food processing chain. In addition, the feasibility of traceability systems depends on a number of factors, including unique identifiers for each genetically modified product, detection methods, permissible levels of contamination, and financial costs. In conclusion, progress has been achieved in the field of sampling, detection, and traceability of genetically modified products, while some issues remain to be solved. For success, much will depend on the threshold level for adventitious contamination set by legislation. Copryright 2004 Elsevier Ltd.

Food Safety Legislation Regarding Of Aflatoxins Contamination

NASA Astrophysics Data System (ADS)

Ketney, Otto

2015-09-01

The main objective of the European Union (EU) is to reduce certain contaminants in foodstuffs to acceptable levels. The occurrence of aflatoxin B1 in food was considered to be one of the most important issues of global food security to protect the health of humans and animals, over 100 nations have established maximum tolerable levels for aflatoxin in food. Although EU legislation covers many aspects of food safety was not legally establish an integrated framework that could effectively combat and cover all sectors of the food chain. Monitoring and reporting levels of aflatoxins after controls are essential actions that assist to identify potential risks to human health. The review process for aflatoxin regulations is a complex activity involving many factors and stakeholders.

New European community strategy for health and safety: the elephant in the room.

PubMed

Woolfson, Charles; Calite, Dace

2007-01-01

Although Lithuania has comprehensive health and safety legislation in line with EU requirements, on a range of general health and occupational health and safety (OHS) indicators, it is a poor performer. Survey data suggest that the norm for work in Lithuania is based on a regime of intensification without a participative working environment in which employees have a voice in safety management. Although European-style legislative reforms appear to be having no measurable effects on CHS performance in post-communist New Member States, the EU OHS strategy for 2007-2012 fails to take account of the deteriorated working environments in these states, suggesting that prospects for harmonization of working environment standards in the enlarged Europe may recede with eastward expansion.

One WEEE, many species: lessons from the European experience.

PubMed

Deepali Sinha Khetriwal; Widmer, Rolf; Kuehr, Ruediger; Huisman, Jaco

2011-09-01

Electrical and electronic equipment (EEE) pervades modern lifestyles, but its quick obsolescence is resulting in huge quantities of EEE to be disposed of. This fast-growing waste stream has been recognized for its hazard potential. The European Union's (EU) Waste Electrical and Electronic Equipment (WEEE) Directive was essentially in response to the toxicity of e-waste - to ensure that it was collected and treated in an environmentally sound manner. Since then, the WEEE Directive has expanded its aims to include recovery of valuable resources as a means to reduce raw material extraction. With these objectives in mind, the Directive sets a common minimum legislative framework for all EU member states. However, the transposition of the Directive into national legislations has meant many differences in actual implementation models. There are 27 national transpositions of the Directive with different definitions, provisions and agreements. Each legislation reflects national situations, whether they are geographical considerations, legislative history, the influence of lobby groups and other national priorities. Although this diversity in legislations has meant massive problems in compliance and enforcement, it provides an opportunity to get an insight into the possible operational models of e-waste legislation. Building on the study by the United Nations University commissioned by the European Commission as part of its 2008 Review of the WEEE Directive, the paper identifies some key features of the Directive as well as legislative and operational differences in transposition and implementation in the various members states. The paper discusses the successes and challenges of the Directive and concludes with lessons learnt from the European experience.

Dynamic visualisation of municipal waste management performance in the EU using Ternary Diagram method.

PubMed

Pomberger, R; Sarc, R; Lorber, K E

2017-03-01

This contribution describes the dynamic visualisation of European (EU 28) municipal waste management performance, using the Ternary Diagram Method. Municipal waste management performance depends primarily on three treatment categories: recycling & composting, incineration and landfilling. The framework of current municipal waste management including recycling targets, etc. is given by the Waste Framework Directive - 2008/98/EC. The proposed Circular Economy Package should stimulate Europe's transition towards more sustainable resources and energy oriented waste management. The Package also includes a revised legislative proposal on waste that sets ambitious recycling rates for municipal waste for 2025 (60%) and 2030 (65%). Additionally, the new calculation method for monitoring the attainment of the targets should be applied. In 2014, ca. 240 million tonnes of municipal waste were generated in the EU. While in 1995, 17% were recycled and composted, 14% incinerated and 64% landfilled, in 2014 ca. 71% were recovered but 28% landfilled only. Considering the treatment performance of the individual EU member states, the EU 28 can be divided into three groups, namely: "Recovery Countries", "Transition Countries" and "Landfilling Countries". Using Ternary Diagram Method, three types of visualization for the municipal waste management performance have been investigated and extensively described. Therefore, for better understanding of municipal waste management performance in the last 20years, dynamic visualisation of the Eurostat table-form data on all 28 member states of the EU has been carried out in three different ways: 1. "Performance Positioning" of waste management unit(s) at a specific date; 2. "Performance dynamics" over a certain time period and; 3. "Performance development" expressed as a track(s). Results obtained show that the Ternary Diagram Method is very well suited to be used for better understanding of past developments and coherences, for monitoring of current situations and prognosis of future paths. One of the interesting coherences shown by the method is the linked development of recycling & composting (60-65%) with incineration (40-35%) performance over the last 20years in the EU 28. Copyright © 2017 Elsevier Ltd. All rights reserved.

Freedom of movement across the EU: legal and ethical issues for children with chronic disease.

PubMed

Mercieca, Cecilia; Aquilina, Kevin; Pullicino, Richard; Borg, Andrew A

2012-11-01

While freedom of movement has been one of the most highly respected human right across the EU, there are various aspects which come into play which still need to be resolved for this to be achieved in practice. One of these key issues is cross border health care. Indeed, there is an increasing awareness of standardisation of health service provision and cross border collaboration in the EU. However, certain groups particularly children may be at risk of suboptimal treatment as a result. We present the case of a child patient which highlights the complexity of this matter spanning family law, health law, social security law as well as ethical issues. EU legislation needs to ensure that children patients have access to high quality care across the EU borders.

Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency.

PubMed

Rose, Klaus; Spigarelli, Michael G

2015-03-23

The European Pediatric Pharmaceutical Legislation wants children to benefit more from pharmaceutical progress. In rare diseases, concerns have been raised that this legislation might damage research and stymie drug development. We discuss the role of the European Medicines Agency (EMA) and its Pediatric Committee (PDCO) in the development of ivacaftor, first-in-class for cystic fibrosis (CF) patients with the G551D mutation (and eight other mutations later) and of lumacaftor and ataluren, two more potential break-through CF medications. Ivacaftor was USA-approved early 2012 and six months later in the EU. Registration was based on the same data. We analyzed these drugs' EU pediatric investigation plans (PIPs) and compared the PIP-studies with the pediatric CF studies listed in www.clinicaltrials.gov. The ivacaftor PIP studies appear to reflect what the developer planned anyway, apart from a study in 1-23-month-olds, which has not yet started. The total negotiation time for the current PIP version was approximately 5.5 years. For companies that develop drugs in pediatric diseases, e.g., CF, PIPs represent considerable additional procedural workload with minimal or no additional benefit for the patients. New drugs for pediatric diseases should not be hampered by additional, unnecessary and costly bureaucracy, but be registered as rapidly as possible without compromising safety.

Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency

PubMed Central

Rose, Klaus; Spigarelli, Michael G.

2015-01-01

The European Pediatric Pharmaceutical Legislation wants children to benefit more from pharmaceutical progress. In rare diseases, concerns have been raised that this legislation might damage research and stymie drug development. We discuss the role of the European Medicines Agency (EMA) and its Pediatric Committee (PDCO) in the development of ivacaftor, first-in-class for cystic fibrosis (CF) patients with the G551D mutation (and eight other mutations later) and of lumacaftor and ataluren, two more potential break-through CF medications. Ivacaftor was USA-approved early 2012 and six months later in the EU. Registration was based on the same data. We analyzed these drugs’ EU pediatric investigation plans (PIPs) and compared the PIP-studies with the pediatric CF studies listed in www.clinicaltrials.gov. The ivacaftor PIP studies appear to reflect what the developer planned anyway, apart from a study in 1–23-month-olds, which has not yet started. The total negotiation time for the current PIP version was approximately 5.5 years. For companies that develop drugs in pediatric diseases, e.g., CF, PIPs represent considerable additional procedural workload with minimal or no additional benefit for the patients. New drugs for pediatric diseases should not be hampered by additional, unnecessary and costly bureaucracy, but be registered as rapidly as possible without compromising safety. PMID:27417354

Relationship of secondhand smoke exposure with sociodemographic factors and smoke-free legislation in the European Union.

PubMed

Filippidis, Filippos T; Agaku, Israel T; Girvalaki, Charis; Jiménez-Ruiz, Carlos; Ward, Brian; Gratziou, Christina; Vardavas, Constantine I

2016-04-01

To explore whether exposure to secondhand smoke (SHS) among non-smokers in the European Union (EU) showed any association with sociodemographic factors and/or the extent of national tobacco control policies. A secondary analysis was performed on data from 26 751 individuals ≥15 years old from 27 EU member states (EU MS), collected during the 2012 Special Eurobarometer survey (wave 77.1). Respondents were asked whether they had been exposed to SHS in eating or drinking establishments during the past 6 months, and/or in their workplace. Data on smoke-free policies were extracted from the European Tobacco Control Status Report and the European Tobacco Control Scale (TCS) in 2013. In total, 29.0% of non-smoking participants reported being exposed to SHS in indoor areas. Males (vs. females) as well as individuals with difficulties to pay bills (vs. those with no difficulties), had significantly greater odds of being exposed to SHS in bars, restaurants and workplaces. For every unit increase of a country's score on the Smoke-free Component of the TCS (indicating greater adherence to smoke-free legislations) the odds ratio of reporting exposure to SHS was 0.82 in bars, 0.85 in restaurants and 0.94 in workplaces. Differences in exposure to SHS clearly exist between and within EU MS, despite the fact that they all have signed the Framework Convention on Tobacco Control, with the burden found to disproportionally affect younger people and individuals with financial difficulties. Moreover, enforcement of smoke-free legislation was inversely associated with SHS exposure, highlighting the importance of enforcing comprehensive smoking bans. © The Author 2015. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

A Welcome Proposal to Amend the GMO Legislation of the EU.

PubMed

Eriksson, Dennis; Harwood, Wendy; Hofvander, Per; Jones, Huw; Rogowsky, Peter; Stöger, Eva; Visser, Richard G F

2018-05-25

Is the European Union (EU) regulatory framework for genetically modified organisms (GMOs) adequate for emerging techniques, such as genome editing? This has been discussed extensively for more than 10 years. A recent proposal from The Netherlands offers a way to break the deadlock. Here, we discuss how the proposal would affect examples from public plant research. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

PubMed

Pauwels, Marleen; Rogiers, Vera

2004-06-15

Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

Public health economic evaluation of different European Union-level policy options aimed at reducing population dietary trans fat intake.

PubMed

Martin-Saborido, Carlos; Mouratidou, Theodora; Livaniou, Anastasia; Caldeira, Sandra; Wollgast, Jan

2016-11-01

The adverse relation between dietary trans fatty acid (TFA) intake and coronary artery disease risk is well established. Many countries in the European Union (EU) and worldwide have implemented different policies to reduce the TFA intake of their populations. The aim of this study was to assess the added value of EU-level action by estimating the cost-effectiveness of 3 possible EU-level policy measures to reduce population dietary TFA intake. This was calculated against a reference situation of not implementing any EU-level policy (i.e., by assuming only national or self-regulatory measures). We developed a mathematical model to compare different policy options at the EU level: 1) to do nothing beyond the current state (reference situation), 2) to impose mandatory TFA labeling of prepackaged foods, 3) to seek voluntary agreements toward further reducing industrially produced TFA (iTFA) content in foods, and 4) to impose a legislative limit for iTFA content in foods. The model indicated that to impose an EU-level legal limit or to make voluntary agreements may, over the course of a lifetime (85 y), avoid the loss of 3.73 and 2.19 million disability-adjusted life-years (DALYs), respectively, and save >51 and 23 billion euros when compared with the reference situation. Implementing mandatory TFA labeling can also avoid the loss of 0.98 million DALYs, but this option incurs more costs than it saves compared with the reference option. The model indicates that there is added value of an EU-level action, either via a legal limit or through voluntary agreements, with the legal limit option producing the highest additional health benefits. Introducing mandatory TFA labeling for the EU common market may provide some additional health benefits; however, this would likely not be a cost-effective strategy.

Public health economic evaluation of different European Union–level policy options aimed at reducing population dietary trans fat intake12

PubMed Central

Mouratidou, Theodora; Livaniou, Anastasia

2016-01-01

Background: The adverse relation between dietary trans fatty acid (TFA) intake and coronary artery disease risk is well established. Many countries in the European Union (EU) and worldwide have implemented different policies to reduce the TFA intake of their populations. Objective: The aim of this study was to assess the added value of EU-level action by estimating the cost-effectiveness of 3 possible EU-level policy measures to reduce population dietary TFA intake. This was calculated against a reference situation of not implementing any EU-level policy (i.e., by assuming only national or self-regulatory measures). Design: We developed a mathematical model to compare different policy options at the EU level: 1) to do nothing beyond the current state (reference situation), 2) to impose mandatory TFA labeling of prepackaged foods, 3) to seek voluntary agreements toward further reducing industrially produced TFA (iTFA) content in foods, and 4) to impose a legislative limit for iTFA content in foods. Results: The model indicated that to impose an EU-level legal limit or to make voluntary agreements may, over the course of a lifetime (85 y), avoid the loss of 3.73 and 2.19 million disability-adjusted life-years (DALYs), respectively, and save >51 and 23 billion euros when compared with the reference situation. Implementing mandatory TFA labeling can also avoid the loss of 0.98 million DALYs, but this option incurs more costs than it saves compared with the reference option. Conclusions: The model indicates that there is added value of an EU-level action, either via a legal limit or through voluntary agreements, with the legal limit option producing the highest additional health benefits. Introducing mandatory TFA labeling for the EU common market may provide some additional health benefits; however, this would likely not be a cost-effective strategy. PMID:27680991

Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?

PubMed

Atzor, Sabine; Gokhale, Surendra; Doherty, Michael

2013-04-01

A perspective from the innovative industry is provided in this article about the long awaited legal proposal for a Clinical Trial Regulation ("Proposal"), adopted in July 2012. With this Proposal, the European Commission reacted to a call by all stakeholders for more harmonization and streamlining of the provisions for conducting clinical trials in the EU. Discrepant approaches between Member States, a failure to respect legal timelines, and a lack of formal coordination mechanisms within and between Member States have resulted in an increased workload for the industry and contributed to a decline in Europe's attractiveness as a place to carry out research and development. The Proposal introduces a concept whereby the sponsor makes a single submission of the clinical trial application dossier to an EU portal, which is followed by a single assessment based on cooperation between Member States. A possibility for the sponsor to choose a 'reporting Member State' to take the lead on key aspects of the assessment is expected to support excellence building and work sharing of Competent Authorities in the EU. The Proposal respects the fact that certain aspects need to be reviewed nationally. The new process aims to lead to a single decision per clinical trial per concerned Member State. The rules are built on the principle of strict adherence to timelines for authorization. The timelines are ambitious but at the same time competitive, as the process builds in mechanisms that strengthen compliance. The rules have been designed to encourage sponsors to file complete submission packages, since any substantial modification to a trial would lead to delays in its commencement. Sponsors need to streamline their internal processes accordingly. In the end, streamlining is an effort that needs to be accepted by all parties involved. The Proposal does not detail how Member States organize the involvement of different bodies, such as Competent Authorities and Ethics Committees, because according to the EU Treaty, the EU cannot legislate on aspects falling into pure Member State competence. The Proposal, however, establishes the assessment objectives on the basis of Good Clinical Practices set by the International Conference on Harmonisation (ICH) and the Declaration of Helsinki by the World Medical Association. As such, the new legislation is likely to have implications on Member States' internal organization. In addition, Ethics Committees in Europe would benefit from an EU platform for best practice exchange-a concept that would need to be requested by the Council and the European Parliament through the legislative process. A single decision system for the entire EU per clinical trial has been discussed as an option, but such an approach was difficult to achieve while respecting national competencies. In this situation, the Proposal represents an acceptable compromise, provided its proposed mechanisms, processes, and timelines are retained upon implementation. As the Proposal is now on the table for discussion by the 27 Member States' governments and by the European Parliament, co-legislators and stakeholders should be aware that any dilution of these provisions would be detrimental to the objective to ensure patient access and make the conditions for clinical research in Europe attractive and fit for the future.

Economic Valuation for Improved Water Quality: Analyzing the Public's Preferences Using Geospatial Analysis

NASA Astrophysics Data System (ADS)

Tsagarakis, Konstantinos P.; Mavragani, Amaryllis; Gemitzi, Alexandra

2017-04-01

As the subject of water quality in the European Union is becoming all the more important, public awareness is of significant importance in exploring ways towards the implementation of better water quality. Over the last decade, significant steps towards this direction have been employed in EU, such as Directive 2008/105/EC and Directive 2013/39/EU and Groundwater Directive and Decision 2015/495. What has been suggested so far is that public participation and information levels are relatively low in some EU countries. This paper focuses on providing a review on economic valuation in EU and in regions with degradated waters by applying geospatial techniques. Overall, it is shown that public awareness and information levels are crucial in better assessing the issues that arise due to water quality, and help better implement EU legislation.

Quality control and the substantive influence of environmental impact assessment in Finland

DOE Office of Scientific and Technical Information (OSTI.GOV)

Poeloenen, Ismo

2006-07-15

This paper focuses on the challenges concerning the quality assurance of environmental impact statements (EIS) in Finland and the European Union. Moreover, the linkage between environmental impact assessment and decision-making is examined from a legal point of view. In addition, the paper includes some comparative remarks concerning the content requirements of examination of alternatives. The study reveals that a significant problem of the Finnish EIA system is the lack of efficient access to a judicial procedure to challenge the quality and completeness of an EIS. Another pitfall is the fact that in certain permit procedures, environmental consideration is so limitedmore » that only a minor part of the EIA can be taken into account. In its current state, EIA legislation in the EU and in Finland does not guarantee that the assessment results filter into decision-making. From the national point of view, the shortcomings can be addressed by amending current legislation concerning licensing procedures so that authorities have the competence and the duty to take environmental matters widely into account in the permit consideration. At the European level, a legislative alternative could be to strengthen the substantive element of the EIA Directive (85/337/EEC). This would increase the weight of EIA related arguments in the national appellate procedures and contribute, in some cases significantly, to the substantive influence of EIA in decision-making.« less

From DTCA-PD to patient information to health information: the complex politics and semantics of EU health policy.

PubMed

Brooks, Eleanor; Geyer, Robert

2012-12-01

Between 2001 and 2011 the pharmaceutical industry, supported by DG Enterprise, was engaged in an ongoing campaign to repeal/amend the European Union (EU) ban on direct-to-consumer advertising of prescription drugs (DTCA-PD). As it became increasingly clear that the ban would not be repealed, DTCA-PD supporters tried to shift the debate away from advertising and towards the provision of 'patient information' and the rights of patients to access such information. Meanwhile, a variety of national and European health organizations, supported by DG SANCO, sought to maintain the ban and oppose the industry-supported 'patient information' campaign. Instead, they promoted a concept of 'health information' that included all aspects of citizens' health, not just pharmaceuticals. This article aims to analyse the transition from DTCA-PD to patient information to health information and examine its implications for EU health policy as a complex policy space. The article examines the emergence and development of EU health policy and the evolution of the DTCA-PD debate through the lens of complexity theory. It analyses the nature of the semantic, political and policy transition and asks why it occurred, what it tells us about EU health policy and future EU health legislation and how it may be understood from a complexity perspective. The article concludes that the complexity framework is ideally suited for the field of public health and, in particular, the DTCA-PD debate. Having successfully shifted the policy-focus of the debate to patients' rights and health information, opponents of the legislation are likely to face their next battle in the realm of cyberspace, where regulatory issues change the nature of advertising. © 2012 Blackwell Publishing Ltd.

Grundwasserökosysteme im Recht? - Eine kritische Betrachtung zur rechtlichen Stellung von Grundwasserökosystemen

NASA Astrophysics Data System (ADS)

Hahn, Hans Jürgen; Schweer, Christian; Griebler, Christian

2018-05-01

Groundwater is the largest and oldest continental biome. However, in the German and EU legislation, groundwater is still considered an abiotic resource rather than an ecosystem. On the other hand, the German Water Act (WHG, Wasserhaushaltsgesetz) mentions groundwaters along with other water bodies that carry the status of ecosystems. Its ecosystem status is also referred to in the preamble of the European Groundwater Directive (EC-GWD). The implementation of groundwater protection measures should be geared to the ecosystemic approach for surface waters contained in the European Water Framework Directive (EC-WFD) and to the German National Biodiversity Strategy (BMU 2007). Addition of the terms "good ecological status" and "groundwater ecosystems" into the German and EU environmental water laws is recommended. Groundwater habitats and species should be subject to impact assessment and included into the FFH directive and German nature conservation laws. There is no technical or legal argument for the discrimination of groundwater ecosystems and species in environmental legislation. The authors argue for the legal equality of ground and surface water, and propose the adaption of the existing legislation according to ecological requirements.

Can a medical need clause help manage the growing costs of prescription drugs in the EU?

PubMed

Brooks, Eleanor; Geyer, Robert

2016-04-01

Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems?

Complementing, competing, or co-operating? Exploring newspapers' portrayals of the European Parliament and national parliaments in EU affairs.

PubMed

Eisele, Olga

2017-06-07

The paper explores newspapers' portrayals of the European Parliament and national parliaments (NPs) in European Union (EU) affairs. To understand underlying perceptions of journalists, it takes public parliamentary activities and looks at their influence on parliaments' news visibility in Finland, Germany and the UK in routine periods in 2011 and 2012. This is done against the background that parliaments, regarded as ultimate legitimisers of state power, depend on the mass media to reach their citizenry. However, journalists follow their own agenda in publishing parliamentary news. In this regard, they may highlight the complementarity, competition or cooperation of parliaments in the EU's unique multi-tier environment. Overall, our results suggest that NPs correspond stronger with newsmakers' anticipation of readership interest. In addition, findings seem to support the assumption that parliaments in the EU are mostly perceived as complementary, separate legislative branches in EU decision-making.

Thirty Years of Orphan Drug Legislation and the Development of Drugs to Treat Rare Seizure Conditions: A Cross Sectional Analysis.

PubMed

Döring, Jan Henje; Lampert, Anette; Hoffmann, Georg F; Ries, Markus

2016-01-01

Epilepsy is a serious chronic health condition with a high morbidity impairing the life of patients and afflicted families. Many epileptic conditions, especially those affecting children, are rare disorders generating an urgent medical need for more efficacious therapy options. Therefore, we assessed the output of the US and European orphan drug legislations. Quantitative analysis of the FDA and EMA databases for orphan drug designations according to STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) criteria. Within the US Orphan Drug Act 40 designations were granted delivering nine approvals, i.e. clobazam, diazepam viscous solution for rectal administration, felbamate, fosphenytoin, lamotrigine, repository corticotropin, rufinamide, topiramate, and vigabatrin. Since 2000 the EMA granted six orphan drug designations whereof two compounds were approved, i.e. rufinamide and stiripentol. In the US, two orphan drug designations were withdrawn. Orphan drugs were approved for conditions including Lennox-Gastaut syndrome, infantile spasms, Dravet syndrome, and status epilepticus. Comparing time to approval for rufinamide, which was approved in the US and the EU to treat rare seizure conditions, the process seems faster in the EU (2.2 years) than in the US (4.3 years). Orphan drug development in the US and in the EU delivered only few molecular entities to treat rare seizure disorders. The development programs focused on already approved antiepileptic drugs or alternative pharmaceutical formulations. Most orphan drugs approved in the US are not approved in the EU to treat rare seizures although some were introduced after 2000 when the EU adopted the Orphan Drug Regulation.

Inorganic arsenic levels in rice milk exceed EU and US drinking water standards.

PubMed

Meharg, Andrew A; Deacon, Claire; Campbell, Robert C J; Carey, Anne-Marie; Williams, Paul N; Feldmann, Joerg; Raab, Andrea

2008-04-01

Under EU legislation, total arsenic levels in drinking water should not exceed 10 microg l(-1), while in the US this figure is set at 10 microg l(-1) inorganic arsenic. All rice milk samples analysed in a supermarket survey (n = 19) would fail the EU limit with up to 3 times this concentration recorded, while out of the subset that had arsenic species determined (n = 15), 80% had inorganic arsenic levels above 10 microg l(-1), with the remaining 3 samples approaching this value. It is a point for discussion whether rice milk is seen as a water substitute or as a food, there are no EU or US food standards highlighting the disparity between water and food regulations in this respect.

Review: In vivo and postmortem effects of feed antioxidants in livestock: a review of the implications on authorization of antioxidant feed additives.

PubMed

Salami, S A; Guinguina, A; Agboola, J O; Omede, A A; Agbonlahor, E M; Tayyab, U

2016-08-01

The pivotal roles of regulatory jurisdictions in the feed additive sector cannot be over-emphasized. In the European Union (EU), antioxidant substances are authorized as feed additives for prolonging the shelf life of feedstuffs based on their effect for preventing lipid peroxidation. However, the efficacy of antioxidants transcends their functional use as technological additives in animal feeds. Promising research results have revealed the in vivo efficacy of dietary antioxidants for combating oxidative stress in production animals. The in vivo effect of antioxidants is significant for enhancing animal health and welfare. Similarly, postmortem effect of dietary antioxidants has been demonstrated to improve the nutritional, organoleptic and shelf-life qualities of animal products. In practice, dietary antioxidants have been traditionally used by farmers for these benefits in livestock production. However, some antioxidants particularly when supplemented in excess could act as prooxidants and exert detrimental effects on animal well-being and product quality. Presently, there is no exclusive legislation in the EU to justify the authorization of antioxidant products for these in vivo and postmortem efficacy claims. To indicate these efficacy claims and appropriate dosage on product labels, it is important to broaden the authorization status of antioxidants through the appraisal of existing EU legislations on feed additives. Such regulatory review will have major impact on the legislative categorization of antioxidants and the efficacy assessment in the technical dossier application. The present review harnesses the scientific investigations of these efficacy claims in production animals and, proposes potential categorization and appraisal of in vivo methodologies for efficacy assessment of antioxidants. This review further elucidates the implication of such regulatory review on the practical application of antioxidants as feed additives in livestock production. Effecting these regulatory changes will stimulate the innovation of more potent antioxidant products and create potential new markets that will have profound economic impacts on the feed additive industry. Based on the in vivo efficacy claims, antioxidants may have to contend with the legislative controversy of either to be considered as veterinary drugs or feed additives. In this scenario, antioxidants are not intended to diagnose or cure diseases as ascribed to veterinary products. This twisted distinction can be logically debated with reference to the stipulated status of feed additives in Commission Regulation (EC) No 1831/2003. Nonetheless, it is imperative for relevant stakeholders in the feed additive industry to lobby for the review of existing EU legislations for authorization of antioxidants for these efficacy claims.

The impact of regulatory compliance behavior on hazardous waste generation in European private healthcare facilities.

PubMed

Botelho, Anabela

2013-10-01

This study empirically evaluates whether the increasingly large numbers of private outpatient healthcare facilities (HCFs) within the European Union (EU) countries comply with the existing European waste legislation, and whether compliance with such legislation affects the fraction of healthcare waste (HCW) classified as hazardous. To that end, this study uses data collected by a large survey of more than 700 small private HCFs distributed throughout Portugal, a full member of the EU since 1986, where 50% of outpatient care is currently dominated by private operators. The collected data are then used to estimate a hurdle model, i.e. a statistical specification in which there are two processes: one is the process by which some HCFs generate zero or some positive fraction of hazardous HCW, and another is the process by which HCFs generate a specific positive fraction of hazardous HCW conditional on producing any. Taken together, the results show that although compliance with the law is far from ideal, it is the strongest factor influencing hazardous waste generation. In particular, it is found that higher compliance has a small and insignificant effect on the probability of generating (or reporting) positive amounts of hazardous waste, but it does have a large and significant effect on the fraction of hazardous waste produced, conditional on producing any, with a unit increase in the compliance rate leading to an estimated decrease in the fraction of hazardous HCW by 16.3 percentage points.

Food nanotechnology – an overview

PubMed Central

Sekhon, Bhupinder S

2010-01-01

Food nanotechnology is an area of emerging interest and opens up a whole universe of new possibilities for the food industry. The basic categories of nanotechnology applications and functionalities currently in the development of food packaging include: the improvement of plastic materials barriers, the incorporation of active components that can deliver functional attributes beyond those of conventional active packaging, and the sensing and signaling of relevant information. Nano food packaging materials may extend food life, improve food safety, alert consumers that food is contaminated or spoiled, repair tears in packaging, and even release preservatives to extend the life of the food in the package. Nanotechnology applications in the food industry can be utilized to detect bacteria in packaging, or produce stronger flavors and color quality, and safety by increasing the barrier properties. Nanotechnology holds great promise to provide benefits not just within food products but also around food products. In fact, nanotechnology introduces new chances for innovation in the food industry at immense speed, but uncertainty and health concerns are also emerging. EU/WE/global legislation for the regulation of nanotechnology in food are meager. Moreover, current legislation appears unsuitable to nanotechnology specificity. PMID:24198465

Clinical Trials, Data Protection and Patient Empowerment in the Era of the New EU Regulations.

PubMed

Negrouk, Anastassia; Horgan, Denis; Gorini, Alessandra; Cutica, Ilaria; Leyens, Lada; Schee genannt Halfmann, Sebastian; Pravettoni, Gabriella

2015-01-01

Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine. © 2015 S. Karger AG, Basel.

Protecting Animals and Enabling Research in the European Union: An Overview of Development and Implementation of Directive 2010/63/EU.

PubMed

Olsson, I Anna S; Silva, Sandra Pinto da; Townend, David; Sandøe, Peter

2016-05-01

In 1986, European Directive 86/609/EEC, regulating the use of animals in research, was one of the first examples of common legislation to set standards for animal protection across the Member States of the former European Economic Community, now the European Union, with the aim of securing a level European playing field. Starting in 2002, a process of revising European animal experimentation legislation was undertaken, with one of its key aims being to ensure high standards of welfare for laboratory animals across Europe. This resulted in Directive 2010/63/EU, which has regulated this activity in Europe since 2013. Since this is a European Union Directive, transposition into national legislation is a necessary and important part of the implementation of the new legislation. This paper gives an overview of the transposition process followed by an analysis of the potential to reach the different objectives of the directive, particularly with a focus on securing the same high standards of animal protection across member countries. The analysis focuses on three separate issues: (1) minimum standards for laboratory animal housing and care, (2) restrictions on the use of certain animal species, and (3) project review and authorization. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Direct-to-consumer genetic testing in Slovenia: availability, ethical dilemmas and legislation.

PubMed

Vrecar, Irena; Peterlin, Borut; Teran, Natasa; Lovrecic, Luca

2015-01-01

Over the last few years, many private companies are advertising direct-to-consumer genetic testing (DTC GT), mostly with no or only minor clinical utility and validity of tests and without genetic counselling. International professional community does not approve provision of DTC GT and situation in some EU countries has been analysed already. The aim of our study was to analyse current situation in the field of DTC GT in Slovenia and related legal and ethical issues. Information was retrieved through internet search, performed independently by two authors, structured according to individual private company and the types of offered genetic testing. Five private companies and three Health Insurance Companies offer DTC GT and it is provided without genetic counselling. Available tests include testing for breast cancer, tests with other health-related information (complex diseases, drug responses) and other tests (nutrigenetic, ancestry, paternity). National legislation is currently being developed and Council of Experts in Medical Genetics has issued an opinion about Genetic Testing and Commercialization of Genetic Tests in Slovenia. Despite the fact that Slovenia has signed the Additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes, DTC GT in Slovenia is present and against all international recommendations. There is lack of or no medical supervision, clinical validity and utility of tests and inappropriate genetic testing of minors is available. There is urgent need for regulation of ethical, legal, and social aspects. National legislation on DTC GT is being prepared.

Use of botanicals in food supplements. Regulatory scope, scientific risk assessment and claim substantiation. 2005.

PubMed

Coppens, P; Delmulle, L; Gulati, O; Richardson, D; Ruthsatz, M; Sievers, H; Sidani, S

2006-01-01

In the European Union, an elaborate legal framework regulates botanical products both under food and medicinal law. The decision as to which legal framework applies to an individual product may differ between the Member States. In the case of botanical food supplements, all food law provisions apply to their manufacturing, composition and marketing, including the new claims legislation. Elements from EU and national law, scientific and other publications are brought together to investigate how to clarify the differentiation between the use of botanicals for medicinal and health-promoting purposes on a scientific basis. Guidance on the safety assessment and quality evaluation of botanicals is proposed in light of the different approaches described in the scientific literature with particular attention to the concept of long-term use as an integral part of safety evaluation. Guidance on claims substantiation is also included, taking into consideration the proposed legislation, the concept of long-term experience and grading of evidence. A model for safety and efficacy assessment of botanical food supplements in the EU is proposed, and should be taken into consideration in the development of legislation and scientific research on botanicals. Copyright 2006 S. Karger AG, Basel.

Selected aspects of tobacco control in Croatia.

PubMed

Loubeau, Patricia R

2009-03-01

This paper seeks to outline the challenges of tobacco consumption control in the transitional economy of Croatia. It focuses on issues of taxation, high unemployment, and smuggling while attempting to meet European Union (EU) accession requirements for tobacco control legislation that reduces smoking consumption. The issue of tobacco control is not a simple one and requires a multi-pronged approach. While Croatia has made good progress in adopting legislation, it needs to strengthen its efforts both in terms of enforcement and increased taxation of cigarettes.

European Union health policy and its implications for national convergence.

PubMed

Cucic, S

2000-06-01

This paper explores the relevance for health care of European Union (EU) legislation, regulation and policies. Reports, communications and other materials of the European Commission and other relevant European bodies are screened for their implications for health care, primarily on the national health system level. The paper provides a brief overview of EU history and its main institutions, followed by an analysis of health (care)-related provisions in the EU's main legal documents--its treaties. The impact of the EU actions on health protection is considered with regard to both actions in the field of public health and health protection requirements in its policies. In the public health area, information systems that are now being developed are discussed, followed by an outline of health protection requirements in EU policies that can have an impact on health systems. These policies are then analysed using the political factions model. Finally an attempt is made to predict future developments, stressing the need for a far-reaching synchronization of national systems.

[Inconsistencies between building regulations in force in Italy for indoor environment and wellness factors].

PubMed

Faggioli, A; Capasso, L

2015-01-01

Indoor environment is one of major health determinants, and the regulations that set the sanitary requirements are of primary importance for the protection of public health. The authors analyse the critical aspects of the complex Italian regulatory system, starting from the EU regulations, through national and regional laws, and finally the municipal regulations. They underline the need for more uniformity and clarity in the determination of health standards, as well as for a simplification of the existing legislation. Moreover, they highlight the importance of controlling and monitoring indoor environment, currently almost completely absent in Italy due to the effects of the regulatory changes of the latest years.

Impact of Waterpipe Tobacco Pack Health Warnings on Waterpipe Smoking Attitudes: A Qualitative Analysis among Regular Users in London.

PubMed

Jawad, Mohammed; Bakir, Ali; Ali, Mohammed; Grant, Aimee

2015-01-01

Despite the rise in prevalence of waterpipe tobacco smoking, it has received little legislative enforcement from governing bodies, especially in the area of health warning labels. Twenty regular waterpipe tobacco smokers from London took part in five focus groups discussing the impact of waterpipe tobacco pack health warnings on their attitudes towards waterpipe smoking. We presented them with existing and mock waterpipe tobacco products, designed to be compliant with current and future UK/EU legislation. Data were analysed using thematic analysis. Participants felt packs were less attractive and health warnings were more impactful as health warnings increased in size and packaging became less branded. However, participants highlighted their lack of exposure to waterpipe tobacco pack health warnings due to the inherent nature of waterpipe smoking, that is, smoking in a café with the apparatus already prepacked by staff. Health warnings at the point of consumption had more reported impact than health warnings at the point of sale. Waterpipe tobacco pack health warnings are likely to be effective if compliant with existing laws and exposed to end-users. Legislations should be reviewed to extend health warning labels to waterpipe accessories, particularly the apparatus, and to waterpipe-serving premises.

Impact of Waterpipe Tobacco Pack Health Warnings on Waterpipe Smoking Attitudes: A Qualitative Analysis among Regular Users in London

PubMed Central

Bakir, Ali; Ali, Mohammed; Grant, Aimee

2015-01-01

Background. Despite the rise in prevalence of waterpipe tobacco smoking, it has received little legislative enforcement from governing bodies, especially in the area of health warning labels. Methods. Twenty regular waterpipe tobacco smokers from London took part in five focus groups discussing the impact of waterpipe tobacco pack health warnings on their attitudes towards waterpipe smoking. We presented them with existing and mock waterpipe tobacco products, designed to be compliant with current and future UK/EU legislation. Data were analysed using thematic analysis. Results. Participants felt packs were less attractive and health warnings were more impactful as health warnings increased in size and packaging became less branded. However, participants highlighted their lack of exposure to waterpipe tobacco pack health warnings due to the inherent nature of waterpipe smoking, that is, smoking in a café with the apparatus already prepacked by staff. Health warnings at the point of consumption had more reported impact than health warnings at the point of sale. Conclusions. Waterpipe tobacco pack health warnings are likely to be effective if compliant with existing laws and exposed to end-users. Legislations should be reviewed to extend health warning labels to waterpipe accessories, particularly the apparatus, and to waterpipe-serving premises. PMID:26273642

Orphan drugs: the regulatory environment.

PubMed

Franco, Pedro

2013-02-01

The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases. Copyright © 2012 Elsevier Ltd. All rights reserved.

ecopa: a powerful concept in the way forward for alternative methods.

PubMed

Rogiers, Vera

2002-12-01

ecopa, the European Consensus-Platform on Alternatives, is an international not-for-profit organisation, based in Belgium and complying with Belgium Law. It is the only quadripartite organisation that promotes the Three Rs at the European level. Ecopa brings together national consensus platforms on alternative methods. Consensus means that all parties concerned are represented, including animal welfare, industry, academia and government. Ecopa currently includes the National Platforms of 14 EU Member State (or future Member State; eight full members, namely, Austria, Belgium, Finland, Germany, The Netherlands, Spain, Switzerland and the UK, and six associate members, being the Czech Republic, Denmark, Italy, Norway, Poland and Sweden). Ecopa also has three working groups, concerned with: a) the 6th Framework Programme of the EC for Research, Technological Development and Demonstration Activities; b) the EC White Paper Strategy for a Future EU Chemicals Policy; and c) the formation of educational programmes on alternative methods within the EU. Ecopa is thus uniquely placed and has huge expertise to offer to the debate around political topics, including the White Paper, the 6th Framework Programme, and the 7th Amendment of the EU Cosmetics Directive. Ecopa should be considered a key stakeholder by the European Commission and Parliament, and it is essential that the views of ecopa are fully incorporated into future legislation. Recently, the ecopa working groups made a strong common statement on the Chemicals Policy White Paper and made a number of recommendations to the Commission based on scientific, practical and realistic grounds. These are to be found on the ecopa Web site (http://www.ecopa.tsx.org/).

European Union's strategy on endocrine disrupting chemicals and the current position of Slovenia.

PubMed

Perharič, Lucija; Fatur, Tanja; Drofenik, Jernej

2016-06-01

In view of the European Union regulations 1107/2009 and 528/2012, which say that basic substances in plant protection and biocidal products marketed in the European Union (EU) should not have an inherent capacity to cause endocrine disruption, an initiative was started to define scientific criteria for the identification of endocrine disruptors (EDs). The objectives of the EU strategy on EDs are to protect human health and the environment, to assure the functioning of the market, and to provide clear and coherent criteria for the identification of EDs that could have broad application in the EU legislation. Policy issues were to be addressed by the Ad-hoc group of Commission Services, EU Agencies and Member States established in 2010, whereas the scientific issues were to be addressed by the Endocrine Disruptors Expert Advisory Group (ED EAG), established in 2011. The ED EAG adopted the 2002 World Health Organization (WHO) definition of endocrine disruptor and agreed that for its identification it is necessary to produce convincing evidence of a biologically plausible causal link between an adverse effect and endocrine disrupting mode of action. In 2014, the European Commission proposed four ED identification criteria options and three regulatory options, which are now being assessed for socio-economic, environmental, and health impact. Slovenia supports the establishing of identification criteria and favours option 4, according to which ED identification should be based on the WHO definition with the addition of potency as an element of hazard characterisation. As for regulatory options, Slovenia favours the risk-based rather than hazard-based regulation.

[Legal aspects of the REACH regulation. The control system of the REACH regulation--new approaches in the EU chemical legislation].

PubMed

Pache, Eckhard

2008-12-01

The REACH regulation from 2006 shall overcome the deficiencies of the previously existing inconsistent legal system of chemicals and build an efficient and innovative regulation for industrial chemicals in the EU. For this purpose, the REACH regulation is not inventing a completely new legislation for chemical substances, but refers to the existing rules, regulates and structures them in a new manner and complements them. With REACH a consistent control system for chemicals in Europe has been created, which basically is managed and coordinated by the newly established European Chemicals Agency (ECHA). In the first phases of the REACH system, information about chemicals is generated and afterwards evaluated. Then this information is used in a process of authorization and restriction, to ensure adequate proliferation and safe exposure to chemical substances. Numerous duties to furnish information complement the readjustment's procedural steps, particularly with regard to the supply chain and down to the consumer. It is mainly affected by the abrogation of the determination between new and existing substances, the principle of substitution and is based on the idea that industry itself is best suited to ensure that the substances it manufactures and places on the market in the EU do not adversely affect human health or the environment.

Controlling new drugs under marketing regulations.

PubMed

Hughes, Brendan; Winstock, Adam R

2012-11-01

The rapid emergence of myriad substances openly marketed as 'legal highs' is straining traditional drug control systems which require time and basic scientific data on harms to react, presenting governments with the dilemma of no response or a disproportionate response. Some countries have side-stepped this using novel policy and legislative approaches. Should other countries consider them? We review the different laws invoked to stop the open sale of new psychoactive substances, focusing on the European Union (EU). Some countries have designed new catch-all control systems, or faster systems to classify substances as drugs. Others have enforced consumer safety or medicines legislation to stop the open sale of these products. The latter originate from harmonization of the internal market of the EU. Rigorous, objective evaluation is required, but first results suggest that these have been effective, while avoiding criminalization of users. Every EU country should have existing laws for protecting public health that can be applied swiftly yet proportionately to new drugs appearing on the open market with minimum political involvement. It seems the key is the speed, not the weight, of response. Given support for their enforcement mechanisms, these systems might be as effective and more efficient than the old ones. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

[Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

PubMed

Kuhlmann-Gottke, Johanna; Duchow, Karin

2015-11-01

At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

The European Working Time Directive and the effects on training of surgical specialists (doctors in training): a position paper of the surgical disciplines of the countries of the EU.

PubMed

Benes, V

2006-11-01

Legislation launched with the EWTD was born as a "Protection of the clinical personnel against overwork for the benefit of Patients" (consumer protection and safety). It appeared that this legislation is in direct and severe conflict with former EU legislation to train competent surgical specialists. First experiences with the EWTD show far reaching and serious consequences on the training of surgical specialists as well as on medical care. There will be a reduction of about 30-35% of clinical and operative experience acquired during the usual 6 yrs of training, with many other negative aspects (see p. 7). All measures proposed so far to overcome the ensuing problems are unworkable. The training of competent surgical specialists as required by the Directive 93/16 EEC is no longer possible and serious problems with safe patient care will occur in the short term, if no political actions are taken. The surgical specialties, represented in the UEMS, provide a proposal for a working hour model consisting of 48 hrs working time (incl. service duties) plus additional 12 hrs reserved and protected for teaching and training. This model would adhere to the EWTD on the one hand, yet maintain the desired standard of training. This proposed exemption from the EWTD would be limited to the time of specialist training. We ask the responsible politicians to find a solution rapidly to prevent serious negative consequences. This motion is supported by the surgical specialties (neurosurgery, general surgery, orthopaedic surgery, paediatric surgery, cardio-thoracic surgery, vascular surgery, oto-rhino-laryngology, list not complete) of the member states of the EU, representing more than 80,000 surgical specialists.

Operational source receptor calculations for large agglomerations

NASA Astrophysics Data System (ADS)

Gauss, Michael; Shamsudheen, Semeena V.; Valdebenito, Alvaro; Pommier, Matthieu; Schulz, Michael

2016-04-01

For Air quality policy an important question is how much of the air pollution within an urbanized region can be attributed to local sources and how much of it is imported through long-range transport. This is critical information for a correct assessment of the effectiveness of potential emission measures. The ratio between indigenous and long-range transported air pollution for a given region depends on its geographic location, the size of its area, the strength and spatial distribution of emission sources, the time of the year, but also - very strongly - on the current meteorological conditions, which change from day to day and thus make it important to provide such calculations in near-real-time to support short-term legislation. Similarly, long-term analysis over longer periods (e.g. one year), or of specific air quality episodes in the past, can help to scientifically underpin multi-regional agreements and long-term legislation. Within the European MACC projects (Monitoring Atmospheric Composition and Climate) and the transition to the operational CAMS service (Copernicus Atmosphere Monitoring Service) the computationally efficient EMEP MSC-W air quality model has been applied with detailed emission data, comprehensive calculations of chemistry and microphysics, driven by high quality meteorological forecast data (up to 96-hour forecasts), to provide source-receptor calculations on a regular basis in forecast mode. In its current state, the product allows the user to choose among different regions and regulatory pollutants (e.g. ozone and PM) to assess the effectiveness of fictive emission reductions in air pollutant emissions that are implemented immediately, either within the agglomeration or outside. The effects are visualized as bar charts, showing resulting changes in air pollution levels within the agglomeration as a function of time (hourly resolution, 0 to 4 days into the future). The bar charts not only allow assessing the effects of emission reduction measures but they also indicate the relative importance of indigenous versus imported air pollution. The calculations are currently performed weekly by MET Norway for the Paris, London, Berlin, Oslo, Po Valley and Rhine-Ruhr regions and the results are provided free of charge at the MACC website (http://www.gmes-atmosphere.eu/services/aqac/policy_interface/regional_sr/). A proposal to extend this service to all EU capitals on a daily basis within the Copernicus Atmosphere Monitoring Service is currently under review. The tool is an important example illustrating the increased application of scientific tools to operational services that support Air Quality policy. This paper will describe this tool in more detail, focusing on the experimental setup, underlying assumptions, uncertainties, computational demand, and the usefulness for air quality for policy. Options to apply the tool for agglomerations outside the EU will also be discussed (making reference to, e.g., PANDA, which is a European-Chinese collaboration project).

Overview of legislation on sewage sludge management in developed countries worldwide.

PubMed

Christodoulou, A; Stamatelatou, K

2016-01-01

The need to apply innovative technologies for maximizing the efficiency and minimizing the carbon footprint of sewage treatment plants has upgraded sewage sludge management to a highly sophisticated research and development sector. Sewage sludge cannot be regarded solely as 'waste'; it is a renewable resource for energy and material recovery. From this perspective, legislation on sewage sludge management tends to incorporate issues related to environmental protection, public health, climate change impacts and socio-economic benefits. This paper reviews the existing legislative frameworks and policies on sewage sludge management in various countries, highlighting the common ground as well as the different priorities in all cases studied. More specifically, the key features of legislation regarding sludge management in developed countries such as the USA, Japan, Australia, New Zealand and the European Union (EU27) are discussed.

Toward the definition of specific protection goals for the environmental risk assessment of chemicals: A perspective on environmental regulation in Europe.

PubMed

Brown, A Ross; Whale, Graham; Jackson, Mathew; Marshall, Stuart; Hamer, Mick; Solga, Andreas; Kabouw, Patrick; Galay-Burgos, Malyka; Woods, Richard; Nadzialek, Stephanie; Maltby, Lorraine

2017-01-01

This critical review examines the definition and implementation of environmental protection goals for chemicals in current European Union (EU) legislation, guidelines, and international agreements to which EU countries are party. The European chemical industry is highly regulated, and prospective environmental risk assessments (ERAs) are tailored for different classes of chemical, according to their specific hazards, uses, and environmental exposure profiles. However, environmental protection goals are often highly generic, requiring the prevention of "unacceptable" or "adverse" impacts on "biodiversity" and "ecosystems" or the "environment as a whole." This review aims to highlight working examples, challenges, solutions, and best practices for defining specific protection goals (SPGs), which are seen to be essential for refining and improving ERA. Specific protection goals hinge on discerning acceptable versus unacceptable adverse effects on the key attributes of relevant, sensitive ecological entities (ranging from organisms to ecosystems). Some isolated examples of SPGs for terrestrial and aquatic biota can be found in prospective ERA guidance for plant protection products (PPPs). However, SPGs are generally limited to environmental or nature legislation that requires environmental monitoring and retrospective ERA. This limitation is due mainly to the availability of baselines, which define acceptable versus unacceptable environmental effects on the key attributes of sentinel species, populations and/or communities, such as reproductive status, abundance, or diversity. Nevertheless, very few regulatory case examples exist in which SPGs incorporate effect magnitude, spatial extent, and temporal duration. We conclude that more holistic approaches are needed for defining SPGs, particularly with respect to protecting population sustainability, ecosystem function, and integrity, which are implicit in generic protection goals and explicit in the International Programme for Chemical Safety (IPCS) definition of "adverse effect." A possible solution, which the chemical industry is currently assessing, is wider application of the ecosystem services approach proposed by the European Food Safety Authority (EFSA) for the risk assessment of PPPs. Integr Environ Assess Manag 2017;13:17-37. © 2016 SETAC. © 2016 SETAC.

Do current European policies support soil multifunctionality?

NASA Astrophysics Data System (ADS)

Helming, Katharina; Glaesner, Nadia; de Vries, Wim

2017-04-01

Soils are multifunctional. Maximising one function, e.g. production of biomass, is often at the costs of the other functions, e.g. water purification, carbon sequestration, nutrient recycling, habitat provision. Sustainable soil management actually means the minimization of trade-offs between multiple soil functions. While Europe does not have a policy that explicitly focuses on soil functions, a number of policies exist in the agricultural, environmental and climate domains that may affect soil functions, in particular food production, water purification, climate change mitigation, biodiversity conservation. The objective of this study was to identify gaps and overlaps in existing EU legislation that is related to soil functions. We conducted a cross-policy analysis of 19 legislative policies at European level. Results revealed two key findings: (i) soil functions are addressed in existing legislation but with the approach to their conservation rather than their improvement. (ii) Different legislations addressed isolated soil functions but there is no policy in place that actually addressed the soil multifunctionality, which is the integrated balancing of the multitude of functions. Because soil degradation is ongoing in Europe, it raises the question whether existing legislation is sufficient for maintaining soil resources and achieving sustainable soil management. Addressing soil functions individually in various directives fails to account for the multifunctionality of soil. Here, research has a role to play to better reveal the interacting processes between soil functions and their sensitivity to soil management decisions and to translate such understanding into policy recommendation. We conclude the presentation with some insights into a research approach that integrates the soil systems into the socio-economic systems to improve the understanding of soil management pressures, soil functional reactions and their impacts on societal value systems, including resource efficiency, ecosystem services and intergenerational equity.

Temporal bone bank: complying with European Union directives on human tissue and cells.

PubMed

Van Rompaey, Vincent; Vandamme, Wouter; Muylle, Ludo; Van de Heyning, Paul H

2012-06-01

Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells. The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel. Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2 years. An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.

Comparative risk analysis of dioxins in fish and fine particles from heavy-duty vehicles.

PubMed

Leino, Olli; Tainio, Marko; Tuomisto, Jouni T

2008-02-01

Dioxins and airborne fine particles are both environmental health problems that have been the subject of active public debate. Knowledge on fine particles has increased substantially during the last 10 years, and even the current, lowered levels in the Europe and in the United States appear to be a major public health problem. On the other hand, dioxins are ubiquitous persistent contaminants, some being carcinogens at high doses, and therefore of great concern. Our aim was to (a) quantitatively analyze the two pollutant health risks and (b) study the changes in risk in view of the current and forthcoming EU legislations on pollutants. We performed a comparative risk assessment for both pollutants in the Helsinki metropolitan area (Finland) and estimated the health effects with several scenarios. For primary fine particles: a comparison between the present emission situation for heavy-duty vehicles and the new fine particle emission standards set by the EU. For dioxins: an EU directive that regulates commercial fishing of Baltic salmon and herring that exceed the dioxin concentration limit set for fish meat, and a derogation (= exemption) from the directive for these two species. Both of these two decisions are very topical issues and this study estimates the expected changes in health effects due to these regulations. It was found that the estimated fine particle risk clearly outweighed the estimated dioxin risk. A substantial improvement to public health could be achieved by initiating reductions in emission standards; about 30 avoided premature deaths annually in the study area. In addition, the benefits of fish consumption due to omega-3 exposure were notably higher than the potential dioxin cancer risk. Both regulations were instigated as ways of promoting public health.

Protection, promotion and support of breast-feeding in Europe: current situation.

PubMed

Cattaneo, Adriano; Yngve, Agneta; Koletzko, Berthold; Guzman, Luis Ruiz

2005-02-01

To describe the current situation regarding protection, promotion and support of breast-feeding in Europe, as a first step towards the development of a blueprint for action. A questionnaire was completed by 29 key informants and 128 other informants in the EU, including member states, accession and candidate countries. EU countries do not fully comply with the policies and recommendations of the Global Strategy on Infant and Young Child Feeding that they endorsed during the 55th World Health Assembly in 2002. Some countries do not even comply with the targets of the Innocenti Declaration (1990). Pre-service training on breast-feeding practice is inadequate and in-service training achieves only low to medium coverage. The Baby Friendly Hospital Initiative is well developed only in three countries; in 19 countries, less than 15% of births occur in baby-friendly hospitals. The International Code of Marketing of Breastmilk Substitutes, endorsed in 1981 by all countries, is not fully applied and submitted to independent monitoring. The legislation for working mothers meets on average the International Labour Organization standards, but covers only women with full formal employment. Voluntary mother-to-mother support groups and trained peer counsellors are present in 27 and 13 countries, respectively. Breast-feeding rates span over a wide range; comparisons are difficult due to use of non-standard methods. The rate of exclusive breast-feeding at 6 months is low everywhere, even in countries with high initiation rates. EU countries need to revise their policies and practices to meet the principles inscribed in the Global Strategy on Infant and Young Child Feeding in order to better protect, promote and support breast-feeding.

Estimating the Public Health Impact of Setting Targets at the European Level for the Reduction of Zoonotic Salmonella in Certain Poultry Populations

PubMed Central

Messens, Winy; Vivas-Alegre, Luis; Bashir, Saghir; Amore, Giusi; Romero-Barrios, Pablo; Hugas, Marta

2013-01-01

In the European Union (EU), targets are being set for the reduction of certain zoonotic Salmonella serovars in different animal populations, including poultry populations, within the framework of Regulation (EC) No. 2160/2003 on the control of zoonoses. For a three-year transitional period, the EU targets were to cover only Salmonella Enteritidis and S. Typhimurium (and in addition S. Hadar, S. Infantis and S. Virchow for breeding flocks of Gallus gallus). Before the end of that transitional period, the revision of the EU targets was to be considered, including the potentially addition of other serovars with public health significance to the permanent EU targets. This review article aims at providing an overview of the assessments carried out by the Scientific Panel on Biological Hazards of the European Food Safety Authority in the field of setting targets for Salmonella in poultry populations (breeding flocks of Gallus gallus, laying flocks of Gallus gallus, broiler flocks of Gallus gallus and flocks of breeding and fattening turkeys) and their impact in subsequent changes in EU legislation. PMID:24157508

The performance of atmospheric pressure gas chromatography-tandem mass spectrometry compared to gas chromatography-high resolution mass spectrometry for the analysis of polychlorinated dioxins and polychlorinated biphenyls in food and feed samples.

PubMed

Ten Dam, Guillaume; Pussente, Igor Cabreira; Scholl, Georges; Eppe, Gauthier; Schaechtele, Alexander; van Leeuwen, Stefan

2016-12-16

Recently, gas chromatography tandem mass spectrometry (GC-MS/MS) has been added in European Union (EU) legislation as an alternative to magnetic sector high resolution mass spectrometry (HRMS) for the analysis of dioxins and dioxin like polychlorinated biphenyls (dl-PCB) in food and feed. In this study the performance of APGC-MS/MS compared to GC-HRMS is investigated and compared with EU legislation. The study includes the legislative parameters, relative intermediate precision standard deviation (S Rw ,rel), trueness, sensitivity, linear range and ion ratio tolerance. In addition, over 200 real samples of large variety and spanning several orders of magnitude in concentration were analyzed by both techniques and the selectivity was evaluated by comparing chromatograms. The S Rw ,rel and trueness were evaluated using (in-house) reference samples and fulfill to EU legislation, though the S Rw ,rel was better with GC-HRMS. The sensitivity was considerably better than of GC-HRMS while the linear range was similar. Ion ratios were mostly within the tolerable range of ±15%. A (temporary unresolved) systematic deviation in ion ratio was observed for several congeners, yet this did not lead to exceeding of the maximum ion ratio limits. The APGC-MS/MS results for the non-dioxin-like-PCBs (ndl-PCBs) were negatively biased, particularly for PCB138 and 153 in contaminated samples. The selectivity of APGC-MS/MS was lower for several matrices. Particularly for contaminated samples, interfering peaks were observed in the APGC chromatograms of the native compounds (dioxins) and labeled internal standards (PCBs). These can lead to biased results and ultimately to false positive samples. It was concluded that the determination of dioxins and PCBs using APGC-MS/MS meets the requirements set by the European Commission. However, due to generally better selectivity and S Rw ,rel, GC-HRMS is the preferred method for monitoring purposes. Copyright © 2016 Elsevier B.V. All rights reserved.

Air pollution control residues from waste incineration: current UK situation and assessment of alternative technologies.

PubMed

Rani, D Amutha; Boccaccini, A R; Deegan, D; Cheeseman, C R

2008-11-01

Current disposal options for APC residues in the UK and alternative treatment technologies developed world-wide have been reviewed. APC residues are currently landfilled in the UK where they undergo in situ solidification, although the future acceptability of this option is uncertain because the EU waste acceptance criteria (WAC) introduce strict limits on leaching that are difficult to achieve. Other APC residue treatment processes have been developed which are reported to reduce leaching to below relevant regulatory limits. The Ferrox process, the VKI process, the WES-PHix process, stabilisation/solidification using cementitious binders and a range of thermal treatment processes are reviewed. Thermal treatment technologies convert APC residues combined with other wastes into inert glass or glass-ceramics that encapsulate heavy metals. The waste management industry will inevitably use the cheapest available option for treating APC residues and strict interpretation and enforcement of waste legislation is required if new, potentially more sustainable technologies are to become commercially viable.

Should the scope of human mixture risk assessment span legislative/regulatory silos for chemicals?

PubMed

Evans, Richard M; Martin, Olwenn V; Faust, Michael; Kortenkamp, Andreas

2016-02-01

Current chemicals regulation operates almost exclusively on a chemical-by-chemical basis, however there is concern that this approach may not be sufficiently protective if two or more chemicals have the same toxic effect. Humans are indisputably exposed to more than one chemical at a time, for example to the multiple chemicals found in food, air and drinking water, and in household and consumer products, and in cosmetics. Assessment of cumulative risk to human health and/or the environment from multiple chemicals and routes can be done in a mixture risk assessment (MRA). Whilst there is a broad consensus on the basic science of mixture toxicology, the path to regulatory implementation of MRA within chemical risk assessment is less clear. In this discussion piece we pose an open question: should the scope of human MRA cross legislative remits or 'silos'? We define silos as, for instance, legislation that defines risk assessment practice for a subset of chemicals, usually on the basis of substance/product, media or process orientation. Currently any form of legal mandate for human MRA in the EU is limited to only a few pieces of legislation. We describe two lines of evidence, illustrated with selected examples, that are particularly pertinent to this question: 1) evidence that mixture effects have been shown for chemicals regulated in different silos and 2) evidence that humans are co-exposed to chemicals from different silos. We substantiate the position that, because there is no reason why chemicals allocated to specific regulatory silos would have non-overlapping risk profiles, then there is also no reason to expect that MRA limited only to chemicals within one silo can fully capture the risk that may be present to human consumers. Finally, we discuss possible options for implementation of MRA and we hope to prompt wider discussion of this issue. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

A modified Delphi study to determine the level of consensus across the European Union on the structures, processes and desired outcomes of the management of polypharmacy in older people

PubMed Central

Gibson-Smith, Kathrine; MacLure, Katie; Mair, Alpana; Alonso, Albert; Codina, Carles; Cittadini, Antonio; Fernandez-Llimos, Fernando; Fleming, Glenda; Gennimata, Dimitra; Gillespie, Ulrika; Harrison, Cathy; Junius-Walker, Ulrike; Kardas, Przemysław; Kempen, Thomas; Kinnear, Moira; Lewek, Pawel; Malva, Joao; McIntosh, Jennifer; Scullin, Claire; Wiese, Birgitt

2017-01-01

Background Inappropriate use of multiple medicines (inappropriate polypharmacy) is a major challenge in older people with consequences of increased prevalence and severity of adverse drug reactions and interactions, and reduced medicines adherence. The aim of this study was to determine the levels of consensus amongst key stakeholders in the European Union (EU) in relation to aspects of the management of polypharmacy in older people. Methods Forty-six statements were developed on aspects of healthcare structures, processes and desired outcomes, with consensus defined at ≥ 80% agreement. Panel members were strategists (e.g. directors, leading clinicians and commissioners) from each of the 28 EU member states, with a target recruitment of five per member state. Three Delphi rounds were conducted via email, with panel members being provided with summative results and collated, anonymised comments at the commencement of Rounds 2 and 3. Results Ninety panel members were recruited (64.3% of target), with high participation levels throughout the three Delphi rounds (91.1%, 83.3%, 72.2%). During Round 1, consensus was obtained for 27/46 statements (58.7%), with an additional two statements in Round 2 and none in Round 3. Consensus was obtained for statements relating to: potential gain arising from polypharmacy management (3/4 statements); strategic development (7/7); change management (5/7) indicator measures (4/6); legislation (0/3); awareness raising (5/5); polypharmacy reviews (5/7); and EU vision (0/7). Analysis of free text comments indicated that the vision statements were too ambitious and not achievable by the specified timeframe of 2025. Conclusion Consensus was obtained amongst key EU strategists around many aspects of polypharmacy management in older people. Notably, no consensus was achieved in relation to statements relating to the need to alter legislation in areas of healthcare delivery, remuneration and practitioner scope of practice. While the vision for the EU by 2025 was considered rather ambitious, there is great potential and clear opportunity to advance polypharmacy management throughout the EU and beyond. PMID:29155870

A modified Delphi study to determine the level of consensus across the European Union on the structures, processes and desired outcomes of the management of polypharmacy in older people.

PubMed

Stewart, Derek; Gibson-Smith, Kathrine; MacLure, Katie; Mair, Alpana; Alonso, Albert; Codina, Carles; Cittadini, Antonio; Fernandez-Llimos, Fernando; Fleming, Glenda; Gennimata, Dimitra; Gillespie, Ulrika; Harrison, Cathy; Junius-Walker, Ulrike; Kardas, Przemysław; Kempen, Thomas; Kinnear, Moira; Lewek, Pawel; Malva, Joao; McIntosh, Jennifer; Scullin, Claire; Wiese, Birgitt

2017-01-01

Inappropriate use of multiple medicines (inappropriate polypharmacy) is a major challenge in older people with consequences of increased prevalence and severity of adverse drug reactions and interactions, and reduced medicines adherence. The aim of this study was to determine the levels of consensus amongst key stakeholders in the European Union (EU) in relation to aspects of the management of polypharmacy in older people. Forty-six statements were developed on aspects of healthcare structures, processes and desired outcomes, with consensus defined at ≥ 80% agreement. Panel members were strategists (e.g. directors, leading clinicians and commissioners) from each of the 28 EU member states, with a target recruitment of five per member state. Three Delphi rounds were conducted via email, with panel members being provided with summative results and collated, anonymised comments at the commencement of Rounds 2 and 3. Ninety panel members were recruited (64.3% of target), with high participation levels throughout the three Delphi rounds (91.1%, 83.3%, 72.2%). During Round 1, consensus was obtained for 27/46 statements (58.7%), with an additional two statements in Round 2 and none in Round 3. Consensus was obtained for statements relating to: potential gain arising from polypharmacy management (3/4 statements); strategic development (7/7); change management (5/7) indicator measures (4/6); legislation (0/3); awareness raising (5/5); polypharmacy reviews (5/7); and EU vision (0/7). Analysis of free text comments indicated that the vision statements were too ambitious and not achievable by the specified timeframe of 2025. Consensus was obtained amongst key EU strategists around many aspects of polypharmacy management in older people. Notably, no consensus was achieved in relation to statements relating to the need to alter legislation in areas of healthcare delivery, remuneration and practitioner scope of practice. While the vision for the EU by 2025 was considered rather ambitious, there is great potential and clear opportunity to advance polypharmacy management throughout the EU and beyond.

Direct access and patient/client self-referral to physiotherapy: a review of contemporary practice within the European Union.

PubMed

Bury, T J; Stokes, E K

2013-12-01

Direct access refers to service users being able to refer themselves to physiotherapy without a third-party referral. It represents a model of practice supported globally by the profession, growing research evidence and health policy in some health systems. To the authors' knowledge, no research has been reported to ascertain the extent to which direct access is available within the physiotherapy profession within the European Union (EU). To survey member organisations of the World Confederation for Physical Therapy (WCPT); establish the number of member states within the EU where it is possible for individuals seeking physiotherapy services to self-refer; describe the legislative/regulatory and reimbursement contexts in which physiotherapy services are delivered; examine if physiotherapy practice is different in member states where direct access is permitted compared with member states where direct access is not permitted; and to describe the barriers and facilitators to direct access perceived by member organisations of the WCPT. Cross-sectional, online survey using a purposive sample. Member organisations of the WCPT in the EU. Direct access is not available in all member states of the EU, despite the majority having legislation to regulate the profession, and entry-level education programmes that produce graduates with the requisite competencies. Key barriers perceived are those that can influence policy development, including the views of the medical profession and politicians. Support of service users and politicians, as well as professional autonomy, are seen as key facilitators. These results represent the first report of a comprehensive mapping of direct access to physiotherapy and contexts within the EU. In over half of member states, service users can self-refer to physiotherapists. These results provide insights to further individuals' understanding about the similarities and differences in working practices and service delivery factors, such as reimbursement across and within EU member states. The synergies between barriers and facilitators indicate the importance of targeted advocacy strategies in the introduction of direct access/self-referral to physiotherapy. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

PubMed

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Depletion study, withdrawal period calculation and bioaccumulation of sulfamethazine in tilapia (Oreochromis niloticus) treated with medicated feed.

PubMed

Nunes, Kátia S D; Vallim, José H; Assalin, Márcia R; Queiroz, Sonia C N; Paraíba, Lourival C; Jonsson, Claudio M; Reyes, Felix G R

2018-04-01

The residue depletion of sulfamethazine (SMZ) was evaluated in tilapia (Oreochromis niloticus) after 11 days of administration of medicated feed containing SMZ, at the dose of 422 mg/kg body weight (bw). The determination of SMZ in feed and tilapia fillet was carried out using the QuEChERS approach for sample preparation, and high performance liquid chromatography with diode array detector (HPLC-DAD) and ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC-QToF-MS) for quantitation, respectively. Both methods were validated based on international and Brazilian guidelines and shown to be suitable for the intended purposes. The withdrawal period to reach the maximum residue level (MRL) of 100 μg/kg, according to the European Union (EU) legislative framework to all substances belonging to the sulfonamide (SA) group (EU, 2010), was 10 days (260 °C-day). After treatment, the maximum level of SMZ accumulation in the tilapia muscle was 1.6 mg/kg. SMZ was shown to be quickly excreted by tilapia. Thus, considering the acceptable daily intake of SMZ established by the Codex Commission (0-0.05 mg/kg bw), and a factor of 5 times the upper amount of fish consumption in Brazil (38 kg/year), this study showed that there is a low risk of adverse effects to consumers. This study offers subsidies not only for the establishment of public policies with regard to the use of veterinary drugs currently not allowed in a country by their legal legislative framework for fish farming, but also to fish producers for the proper handling to ensure safe fish fillets. Copyright © 2018 Elsevier Ltd. All rights reserved.

Hygiene inspections on passenger ships in Europe - an overview

PubMed Central

2010-01-01

Background Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU) countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS) and European Free Trade Association countries. Methods Two questionnaires were composed and disseminated to 28 countries. A total of 92 questionnaires were completed by competent authorities responsible for hygiene inspections (n = 48) and the creation of legislation (n = 44); response rates were 96%, and 75.9%, respectively. Results Out of the 48 responding authorities responsible for hygiene inspections, a routine programme was used by 19 (39.6%) of these to conduct inspections of ships on national voyages and by 26 (54.2%) for ships on international voyages. Standardised inspection forms are used by 59.1% of the authorities. A scoring inspection system is applied by five (11.6%) of the 43 responding authorities. Environmental sampling is conducted by 84.1% of the authorities (37 out of 44). The inspection results are collected and analysed by 54.5% (24 out of 44) of the authorities, while 9 authorities (20.5%) declared that they publish the results. Inspections are conducted during outbreak investigations by 75% and 70.8% of the authorities, on ships on national and international voyages, respectively. A total of 31 (64.6%) and 39 (81.3%) authorities conducted inspections during complaint investigations on ships on international and on national voyages, respectively. Port-to-port communication between the national port authorities was reported by 35.4% (17 out of 48) of the responding authorities and 20.8% (10 out of 48) of the port authorities of other countries. Conclusion This study revealed a diversity of approaches and practices in the conduct of inspections, differences in the qualifications/knowledge/experience of inspectors, the legislation applied during inspections, and the lack of communication and training among many EU countries. An integrated European inspection programme involving competent expert inspectors in each EU Member States and special training for ship hygiene delivered to crew members and inspectors would help to minimize the risk of communicable diseases. Common inspection tools at a European level for hygiene inspection practices and port-to-port communication are needed. PMID:20219097

Hygiene inspections on passenger ships in Europe - an overview.

PubMed

Mouchtouri, Varvara A; Westacott, Sandra; Nichols, Gordon; Riemer, Tobias; Skipp, Mel; Bartlett, Christopher L R; Kremastinou, Jenny; Hadjichristodoulou, Christos

2010-03-10

Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU) countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS) and European Free Trade Association countries. Two questionnaires were composed and disseminated to 28 countries. A total of 92 questionnaires were completed by competent authorities responsible for hygiene inspections (n = 48) and the creation of legislation (n = 44); response rates were 96%, and 75.9%, respectively. Out of the 48 responding authorities responsible for hygiene inspections, a routine programme was used by 19 (39.6%) of these to conduct inspections of ships on national voyages and by 26 (54.2%) for ships on international voyages. Standardised inspection forms are used by 59.1% of the authorities. A scoring inspection system is applied by five (11.6%) of the 43 responding authorities. Environmental sampling is conducted by 84.1% of the authorities (37 out of 44). The inspection results are collected and analysed by 54.5% (24 out of 44) of the authorities, while 9 authorities (20.5%) declared that they publish the results. Inspections are conducted during outbreak investigations by 75% and 70.8% of the authorities, on ships on national and international voyages, respectively. A total of 31 (64.6%) and 39 (81.3%) authorities conducted inspections during complaint investigations on ships on international and on national voyages, respectively. Port-to-port communication between the national port authorities was reported by 35.4% (17 out of 48) of the responding authorities and 20.8% (10 out of 48) of the port authorities of other countries. This study revealed a diversity of approaches and practices in the conduct of inspections, differences in the qualifications/knowledge/experience of inspectors, the legislation applied during inspections, and the lack of communication and training among many EU countries. An integrated European inspection programme involving competent expert inspectors in each EU Member States and special training for ship hygiene delivered to crew members and inspectors would help to minimize the risk of communicable diseases. Common inspection tools at a European level for hygiene inspection practices and port-to-port communication are needed.

Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.

PubMed

Permanand, Govin; Mossialos, Elias; McKee, Martin

2006-01-01

Following a review process lasting almost four years, and culminating in several pieces of new European legislation, adjustments have been made to the European Union's (EU) regulatory framework for pharmaceuticals. The European Commission laid out its priorities for the review as: simplifying the authorisation system, ensuring a high quality of public health, completing the internal market in medicines, and preparing for the enlargement of the Union. Amongst the most important changes brought about by the new rules are those relating to the European drug approval procedures, the functions and operational transparency of the European Medicines Agency (EMEA), and the EU's pharmacovigilance system. This article provides a brief examination of key elements of these changes, and considers the extent to which they serve the goal of improved public health protection within the EU.

Tracing artificial trans fat in popular foods in Europe: a market basket investigation.

PubMed

Stender, Steen; Astrup, Arne; Dyerberg, Jørn

2014-05-20

To minimise the intake of industrial artificial trans fat (I-TF), nearly all European countries rely on food producers to voluntarily reduce the I-TF content in food. The objective of this study was to investigate the effect of this strategy on I-TF content in prepackaged biscuits/cakes/wafers in 2012-2013 in 20 European countries. The I-TF content was assessed in a market basket investigation. Three large supermarkets were visited in each capital, and in some countries, three additional ethnic shops were included. A total of 598 samples of biscuits/cakes/wafers with 'partially hydrogenated vegetable fat' or a similar term high on the list of ingredients were analysed, 312 products had more than 2% of fat as I-TF, exceeding the legislatively determined I-TF limit in Austria and Denmark; the mean (SD) was 19 (7)%. In seven countries, no I-TF was found, whereas nine predominantly Eastern European countries had products with very high I-TF content, and the remaining four countries had intermediate levels. Of the five countries that were examined using the same procedure as in 2006, three had unchanged I-TF levels in 2013, and two had lower levels. The 18 small ethnic shops examined in six Western European countries sold 83 products. The mean (SD) was 23 (12)% of the fat as I-TF, all imported from countries in Balkan. In Sweden, this type of food imported from Balkan was also available in large supermarkets. The findings suggest that subgroups of the population in many countries in Europe still consume I-TF in amounts that increase their risk of coronary heart disease. Under current European Union (EU) legislation, the sale of products containing I-TF is legal but conflicts with the WHO recommendation to minimise the intake of I-TF. An EU-legislative limit on I-TF content in foods is expected to be an effective strategy to achieve this goal. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Defining a common set of indicators to monitor road accidents in the European Union.

PubMed

Farchi, Sara; Molino, Nunzio; Giorgi Rossi, Paolo; Borgia, Piero; Krzyzanowski, Michael; Dalbokova, Dafina; Kim, Rokho

2006-07-11

currently road accidents are mostly monitored through mortality and injury rates. This paper reports the methodology and the results of a project set forth by the European Union (EU) and coordinated by the WHO aimed at identifying and evaluating a core set of indicators to monitor the causal chain of road accident health effects. The project is part of the ECOEHIS (Development of Environment and Health Indicators for European Union Countries). a group of experts (WG), identified 14 indicators after a review of the information collected at the EU level, each of them representing a specific aspect of the DPSEEA (Driving, Pressure, State, Exposure, Effect, Action) model applied and adapted to the road accidents. Each indicator was scored according to a list of 16 criteria chosen by the WG. Those found to have a high score were analysed to determine if they were compatible with EU legislation and then tested in the feasibility study. 11 of the 14 indicators found to be relevant and compatible with the criteria of selection were proposed for the feasibility study. Mortality, injury, road accident rate, age of vehicle fleet, and distance travelled are the indicators recommended for immediate implementation. after overcoming the limitations that emerged (absence of a common definition of death by road accident and injury severity, underestimation of injuries, differences in information quality) this core set of indicators will allow Member States to carry out effective internal/external comparisons over time.

Defining a common set of indicators to monitor road accidents in the European Union

PubMed Central

Farchi, Sara; Molino, Nunzio; Giorgi Rossi, Paolo; Borgia, Piero; Krzyzanowski, Michael; Dalbokova, Dafina; Kim, Rokho

2006-01-01

Background currently road accidents are mostly monitored through mortality and injury rates. This paper reports the methodology and the results of a project set forth by the European Union (EU) and coordinated by the WHO aimed at identifying and evaluating a core set of indicators to monitor the causal chain of road accident health effects. The project is part of the ECOEHIS (Development of Environment and Health Indicators for European Union Countries). Methods a group of experts (WG), identified 14 indicators after a review of the information collected at the EU level, each of them representing a specific aspect of the DPSEEA (Driving, Pressure, State, Exposure, Effect, Action) model applied and adapted to the road accidents. Each indicator was scored according to a list of 16 criteria chosen by the WG. Those found to have a high score were analysed to determine if they were compatible with EU legislation and then tested in the feasibility study. Results 11 of the 14 indicators found to be relevant and compatible with the criteria of selection were proposed for the feasibility study. Mortality, injury, road accident rate, age of vehicle fleet, and distance travelled are the indicators recommended for immediate implementation. Conclusion after overcoming the limitations that emerged (absence of a common definition of death by road accident and injury severity, underestimation of injuries, differences in information quality) this core set of indicators will allow Member States to carry out effective internal/external comparisons over time. PMID:16834780

The need for strategic development of safety sciences.

PubMed

Busquet, Francois; Hartung, Thomas

2017-01-01

The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Europe. We argue that there is need for scientific developments not only for the tools but also for their application, i.e., a need for Regulatory Science or, perhaps better, Safety Science. While some of this is emerging on the US side as strategic reports, e.g., from the National Academies, the NIH and the regulatory agencies, especially the EPA and the FDA, such strategic developments beyond technological developments are largely lacking in Europe or have started only recently at EFSA, ECHA or within the flagship project EU-ToxRisk. This article provides a rationale for the creation of a European Safety Sciences Institute (ESSI) based on regulatory and scientific needs, political context and current EU missions. Moreover, the possible modus operandi of ESSI will be described along with possible working formats as well as anticipated main tasks and duties. This mirrors the triple alliance on the American side (US EPA, NIH and FDA) in revamping regulatory sciences. Moreover, this could fit the political agenda of the European Commission for better implementation of existing EU legislation rather than creating new laws.

Discrimination and Good Practice Activities in Education: Trends and Developments in the 27 EU Member States

ERIC Educational Resources Information Center

Pollak, Alexander

2008-01-01

The European Union Agency for Fundamental Rights collects, through its network of observation points, information on discrimination and good practice in the areas of legislation, employment, housing, racist violence, and education. Data on education includes information on: access to education for vulnerable groups, discriminatory practices,…

Responsible decision-making for plant research and breeding innovations in the European Union.

PubMed

Eriksson, Dennis; Chatzopoulou, Sevasti

2018-01-02

Plant research and breeding has made substantial technical progress over the past few decades, indicating a potential for tremendous societal impact. Due to this potential, the development of policies and legislation on plant breeding and the technical progress should preferably involve all relevant stakeholders. However, we argue here that there is a substantial imbalance in the European Union (EU) regarding the influence of the various stakeholder groups on policy makers. We use evidence from three examples in order to show that the role of science is overlooked: 1) important delays in the decision process concerning the authorization of genetically modified (GM) maize events, 2) the significance attributed to non-scientific reasons in new legislation concerning the prohibition of GM events in EU member states, and 3) failure of the European Commission to deliver legal guidance to new plant breeding techniques despite sufficient scientific evidence and advisory reports. We attribute this imbalance to misinformation and misinterpretation of public perceptions and a disproportionate attention to single outlier reports, and we present ideas on how to establish a better stakeholder balance within this field.

The Mycotox Charter: Increasing Awareness of, and Concerted Action for, Minimizing Mycotoxin Exposure Worldwide

PubMed Central

Logrieco, Antonio F.; Eskola, Mari; Krska, Rudolf; Ayalew, Amare; Bhatnagar, Deepak; Chulze, Sofia; Li, Peiwu; Poapolathep, Amnart; Rahayu, Endang S.; Shephard, Gordon S.; Stepman, François; Zhang, Hao

2018-01-01

Mycotoxins are major food contaminants affecting global food security, especially in low and middle-income countries. The European Union (EU) funded project, MycoKey, focuses on “Integrated and innovative key actions for mycotoxin management in the food and feed chains” and the right to safe food through mycotoxin management strategies and regulation, which are fundamental to minimizing the unequal access to safe and sufficient food worldwide. As part of the MycoKey project, a Mycotoxin Charter (charter.mycokey.eu) was launched to share the need for global harmonization of mycotoxin legislation and policies and to minimize human and animal exposure worldwide, with particular attention to less developed countries that lack effective legislation. This document is in response to a demand that has built through previous European Framework Projects—MycoGlobe and MycoRed—in the previous decade to control and reduce mycotoxin contamination worldwide. All suppliers, participants and beneficiaries of the food supply chain, for example, farmers, consumers, stakeholders, researchers, members of civil society and government and so forth, are invited to sign this charter and to support this initiative. PMID:29617309

Liquid chromatography-electrospray ionization tandem mass spectrometry and dynamic multiple reaction monitoring method for determining multiple pesticide residues in tomato.

PubMed

Andrade, G C R M; Monteiro, S H; Francisco, J G; Figueiredo, L A; Botelho, R G; Tornisielo, V L

2015-05-15

A quick and sensitive liquid chromatography-electrospray ionization tandem mass spectrometry method, using dynamic multiple reaction monitoring and a 1.8-μm particle size analytical column, was developed to determine 57 pesticides in tomato in a 13-min run. QuEChERS (quick, easy, cheap, effective, rugged, and safe) method for samples preparations and validations was carried out in compliance with EU SANCO guidelines. The method was applied to 58 tomato samples. More than 84% of the compounds investigated showed limits of detection equal to or lower than 5 mg kg(-1). A mild (<20%), medium (20-50%), and strong (>50%) matrix effect was observed for 72%, 25%, and 3% of the pesticides studied, respectively. Eighty-one percent of the pesticides showed recoveries ranging between 70% and 120%. Twelve pesticides were detected in 35 samples, all below the maximum residue levels permitted in the Brazilian legislation; 15 samples exceeded the maximum residue levels established by the EU legislation for methamidophos; and 10 exceeded limits for acephate and four for bromuconazole. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Mycotox Charter: Increasing Awareness of, and Concerted Action for, Minimizing Mycotoxin Exposure Worldwide.

PubMed

Logrieco, Antonio F; Miller, J David; Eskola, Mari; Krska, Rudolf; Ayalew, Amare; Bandyopadhyay, Ranajit; Battilani, Paola; Bhatnagar, Deepak; Chulze, Sofia; De Saeger, Sarah; Li, Peiwu; Perrone, Giancarlo; Poapolathep, Amnart; Rahayu, Endang S; Shephard, Gordon S; Stepman, François; Zhang, Hao; Leslie, John F

2018-04-04

Mycotoxins are major food contaminants affecting global food security, especially in low and middle-income countries. The European Union (EU) funded project, MycoKey, focuses on “Integrated and innovative key actions for mycotoxin management in the food and feed chains” and the right to safe food through mycotoxin management strategies and regulation, which are fundamental to minimizing the unequal access to safe and sufficient food worldwide. As part of the MycoKey project, a Mycotoxin Charter (charter.mycokey.eu) was launched to share the need for global harmonization of mycotoxin legislation and policies and to minimize human and animal exposure worldwide, with particular attention to less developed countries that lack effective legislation. This document is in response to a demand that has built through previous European Framework Projects—MycoGlobe and MycoRed—in the previous decade to control and reduce mycotoxin contamination worldwide. All suppliers, participants and beneficiaries of the food supply chain, for example, farmers, consumers, stakeholders, researchers, members of civil society and government and so forth, are invited to sign this charter and to support this initiative.

Estimation of end of life mobile phones generation: the case study of the Czech Republic.

PubMed

Polák, Miloš; Drápalová, Lenka

2012-08-01

The volume of waste electrical and electronic equipment (WEEE) has been rapidly growing in recent years. In the European Union (EU), legislation promoting the collection and recycling of WEEE has been in force since the year 2003. Yet, both current and recently suggested collection targets for WEEE are completely ineffective when it comes to collection and recycling of small WEEE (s-WEEE), with mobile phones as a typical example. Mobile phones are the most sold EEE and at the same time one of appliances with the lowest collection rate. To improve this situation, it is necessary to assess the amount of generated end of life (EoL) mobile phones as precisely as possible. This paper presents a method of assessment of EoL mobile phones generation based on delay model. Within the scope of this paper, the method has been applied on the Czech Republic data. However, this method can be applied also to other EoL appliances in or outside the Czech Republic. Our results show that the average total lifespan of Czech mobile phones is surprisingly long, exactly 7.99 years. We impute long lifespan particularly to a storage time of EoL mobile phones at households, estimated to be 4.35 years. In the years 1990-2000, only 45 thousands of EoL mobile phones were generated in the Czech Republic, while in the years 2000-2010 the number grew to 6.5 million pieces and it is estimated that in the years 2010-2020 about 26.3 million pieces will be generated. Current European legislation sets targets on collection and recycling of WEEE in general, but no specific collection target for EoL mobile phone exists. In the year 2010 only about 3-6% of Czech EoL mobile phones were collected for recovery and recycling. If we make similar estimation using an estimated average EU value, then within the next 10 years about 1.3 billion of EoL mobile phones would be available for recycling in the EU. This amount contains about 31 tonnes of gold and 325 tonnes of silver. Since Europe is dependent on import of many raw materials, efficient recycling of EoL products could help reduce this dependence. To set a working system of collection, it will be necessary to set new and realistic collection targets. Copyright © 2012 Elsevier Ltd. All rights reserved.

Emerging food safety issues: An EU perspective.

PubMed

McEvoy, John D G

2016-05-01

Safe food is the right of every citizen of the European Union (EU). A comprehensive and dynamic framework of food and feed safety legislation has been put in place and the EU's executive arm - the European Commission - is responsible for ensuring that the EU member states apply food law consistently. Similarly, the Commission plays an important role in ensuring that imported food meets the EU's stringent food safety standards. Consumer perceptions of unsafe food tend to focus on acute outbreaks of bacterial or viral origin. In recent years there have been a number of diverse food crises associated with fraudulent activity which may (e.g. melamine in dairy products in China) or may not (e.g. the horse meat scandal in the EU) represent a genuine food safety risk. Well publicized incidents of chronic exposure to chemical contamination in the EU (e.g. dioxins in meat and mycotoxins in nuts) have required robust coordinated policy responses from the Commission. Despite the decreasing incidence of non-compliant residues of veterinary medicinal products and banned substances in animal products, EU consumers are increasingly concerned about the use of such products in food-producing animals, including in the context of the build-up of antimicrobial resistance in animals and transfer to humans. The Commission plays a key role in coordination of the EU member states' responses to such incidents, in risk management, and in preparation for emerging issues. This paper focuses on how the EU as a whole has dealt with a number of food crises, and what can be learned from past incidents. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Determination of genetic toxicity and potential carcinogenicity in vitro--challenges post the Seventh Amendment to the European Cosmetics Directive.

PubMed

Tweats, D J; Scott, A D; Westmoreland, C; Carmichael, P L

2007-01-01

Genetic toxicology and its role in the detection of carcinogens is currently undergoing a period of reappraisal. There is an increasing interest in developing alternatives to animal testing and the three R's of reduction, refinement and replacement are the basis for EU and national animal protection laws the Seventh Amendment to the EU Cosmetics Directive will ban the marketing of cosmetic/personal care products that contain ingredients that have been tested in animal models. Thus in vivo tests such as the bone marrow micronucleus test, which has a key role in current testing strategies for genotoxicity, will not be available for this class of products. The attrition rate for new, valuable and safe chemicals tested in an in vitro-only testing battery, using the in vitro tests currently established for genotoxicity screening, will greatly increase once this legislation is in place. In addition there has been an explosion of knowledge concerning the cellular and molecular events leading to carcinogenesis. This knowledge has not yet been fully factored into screening chemicals for properties that are not directly linked to mutation induction. Thus there is a pressing need for new, more accurate approaches to determine genotoxicity and carcinogenicity. However, a considerable challenge is presented for these new approaches to be universally accepted and new tests sufficiently validated by March 2009 when the animal testing and marketing bans associated with the Seventh Amendment are due to come into force. This commentary brings together ideas and approaches from several international workshops and meetings to consider these issues.

Comparison of China's Environmental Impact Assessment (EIA) law with the European Union (EU) EIA Directive.

PubMed

Chen, Qiaoling; Zhang, Yuanzhi; Ekroos, Ari

2007-09-01

In this paper, we first review the development of China's Environmental Impact Assessment (EIA) system in the past 30 years. Then we compare the framework and operational procedures of China's new EIA law with those of the EU EIA Directive. We also compare public participation, as well as sanctions and control in the two EIA systems. In addition, we identify where the processes in both EIA systems are similar or different from one another. By comparison, we noted that there are at least three obvious weaknesses in China's EIA system: (1) the application of new models for EIA legislation; (2) the improvement of EIA guidance and education; and (3) the enhancement of public participation in EIA process. Our study indicates that these three major shortcomings should be overcome and improved in China's EIA system, when compared with the EU EIA system.

EU actions to ensure the safety of tattoos and the protection of consumers.

PubMed

Rico, Ana María Blass

2015-01-01

The number of tattooed persons has been continuously increasing in the last few years, particularly in the younger population. At the same time, the possibility of purchasing tattoo inks online is easier than ever worldwide. Consumers are not always sufficiently aware of the possible health problems associated with this 'cool fashion' if hygiene conditions are not respected and/or if the injected mixtures contain dangerous chemicals. Concerns about the possible health risks associated with such practices arise from the absence of a clear legislative framework, the lack of proper risk assessment of the chemicals used, and non-harmonised or missing hygiene and purity requirements, among other factors. There is a general consensus among all active stakeholders that EU harmonised rules would help to ensure a consistent high level of protection of consumers across the EU. © 2015 S. Karger AG, Basel.

Food safety - the roles and responsibilities of different sectors

NASA Astrophysics Data System (ADS)

Karabasil, N.; Bošković, T.; Dimitrijević, M.; Vasilev, D.; Đorđević, V.; Lakićević, B.; Teodorović, V.

2017-09-01

Serbia is a relatively small country but with a long tradition in food production, especially meat and meat products. Serbia, as part of its open negotiation process as a candidate country with the European Union (EU), started to harmonise its legislation with the EU, and has published a set of laws and regulations relating to the hygiene of food production and food safety, the official control of production and the welfare of animals. Therefore, the food safety system in Serbia is based on principles established in the EU. There is a need for cooperation of different sectors (government, food business operators and consumers) in the management of food safety, and every sector has its role and responsibility. This paper aims to provide analytical support for the process of upgrading safety and quality in Serbia’s food sector and explains the roles and responsibilities of different sectors in the food chain.

Evaluation of EU legislation on blood: a bioethical point of view.

PubMed

Petrini, Carlo

2017-01-01

A review of the European Union (EU) regulations concerning blood, tissues, and cells of human origin is under way in the EU. From the ethical point of view, the non-remuneration of donations and the ban on deriving gain from human biological materials are of particular significance. While the basic ethical principles involved in the procurement, preservation, and use of these materials are the same, their practical application should be adapted to the specific context of each material. In the case of donation and use of blood, in particular, the issue of legitimate reimbursements to donors and for transfusion centers has to be managed in accordance with the principle of non-commercialization. There is also a need for strict rules to avoid possible commercial spillover effects from blood-derived products. The author proposes ethical criteria regarding reimbursements to donors, costs associated with processing, and the development (and possible marketing) of products.

Freedom of Movement: From Right to Possibility--Recognition of Qualifications through Legislation or Information

ERIC Educational Resources Information Center

Paulsen, Mette Beyer

2008-01-01

This article seeks to describe briefly various initiatives taken to ease recognition and comparison of formal qualifications across borders in the EU. It takes a political angle, from binding legal instruments such as directives and decisions to policy instruments such as recommendations and voluntary action and covers 27 Member States with very…

A straightforward method to determine flavouring substances in food by GC-MS.

PubMed

Lopez, Patricia; van Sisseren, Maarten; De Marco, Stefania; Jekel, Ad; de Nijs, Monique; Mol, Hans G J

2015-05-01

A straightforward GC-MS method was developed to determine the occurrence of fourteen flavouring compounds in food. It was successfully validated for four generic types of food (liquids, semi-solids, dry solids and fatty solids) in terms of limit of quantification, linearity, selectivity, matrix effects, recovery (53-120%) and repeatability (3-22%). The method was applied to a survey of 61 Dutch food products. The survey was designed to cover all the food commodities for which the EU Regulation 1334/2008 set maximum permitted levels. All samples were compliant with EU legislation. However, the levels of coumarin (0.6-63 mg/kg) may result in an exposure that, in case of children, would exceed the tolerable daily intake (TDI) of 0.1mg/kg bw/day. In addition to coumarin, estragole, methyl-eugenol, (R)-(+)-pulegone and thujone were EU-regulated substances detected in thirty-one of the products. The non-EU regulated alkenylbenzenes, trans-anethole and myristicin, were commonly present in beverages and in herbs-containing products. Copyright © 2014 Elsevier Ltd. All rights reserved.

Modelling NO2 concentrations at the street level in the GAINS integrated assessment model: projections under current legislation

NASA Astrophysics Data System (ADS)

Kiesewetter, G.; Borken-Kleefeld, J.; Schöpp, W.; Heyes, C.; Thunis, P.; Bessagnet, B.; Gsella, A.; Amann, M.

2013-08-01

NO2 concentrations at the street level are a major concern for urban air quality in Europe and have been regulated under the EU Thematic Strategy on Air Pollution. Despite the legal requirements, limit values are exceeded at many monitoring stations with little or no improvement during recent years. In order to assess the effects of future emission control regulations on roadside NO2 concentrations, a downscaling module has been implemented in the GAINS integrated assessment model. The module follows a hybrid approach based on atmospheric dispersion calculations and observations from the AirBase European air quality data base that are used to estimate site-specific parameters. Pollutant concentrations at every monitoring site with sufficient data coverage are disaggregated into contributions from regional background, urban increment, and local roadside increment. The future evolution of each contribution is assessed with a model of the appropriate scale - 28 × 28 km grid based on the EMEP Model for the regional background, 7 × 7 km urban increment based on the CHIMERE Chemistry Transport Model, and a chemical box model for the roadside increment. Thus, different emission scenarios and control options for long-range transport, regional and local emissions can be analysed. Observed concentrations and historical trends are well captured, in particular the differing NO2 and total NOx = NO + NO2 trends. Altogether, more than 1950 air quality monitoring stations in the EU are covered by the model, including more than 400 traffic stations and 70% of the critical stations. Together with its well-established bottom-up emission and dispersion calculation scheme, GAINS is thus able to bridge the scales from European-wide policies to impacts in street canyons. As an application of the model, we assess the evolution of attainment of NO2 limit values under current legislation until 2030. Strong improvements are expected with the introduction of the Euro 6 emission standard for light duty vehicles; however, for some major European cities, further measures may be required, in particular if aiming to achieve compliance at an earlier time.

Modelling NO2 concentrations at the street level in the GAINS integrated assessment model: projections under current legislation

NASA Astrophysics Data System (ADS)

Kiesewetter, G.; Borken-Kleefeld, J.; Schöpp, W.; Heyes, C.; Thunis, P.; Bessagnet, B.; Terrenoire, E.; Gsella, A.; Amann, M.

2014-01-01

NO2 concentrations at the street level are a major concern for urban air quality in Europe and have been regulated under the EU Thematic Strategy on Air Pollution. Despite the legal requirements, limit values are exceeded at many monitoring stations with little or no improvement in recent years. In order to assess the effects of future emission control regulations on roadside NO2 concentrations, a downscaling module has been implemented in the GAINS integrated assessment model. The module follows a hybrid approach based on atmospheric dispersion calculations and observations from the AirBase European air quality database that are used to estimate site-specific parameters. Pollutant concentrations at every monitoring site with sufficient data coverage are disaggregated into contributions from regional background, urban increment, and local roadside increment. The future evolution of each contribution is assessed with a model of the appropriate scale: 28 × 28 km grid based on the EMEP Model for the regional background, 7 × 7 km urban increment based on the CHIMERE Chemistry Transport Model, and a chemical box model for the roadside increment. Thus, different emission scenarios and control options for long-range transport as well as regional and local emissions can be analysed. Observed concentrations and historical trends are well captured, in particular the differing NO2 and total NOx = NO + NO2 trends. Altogether, more than 1950 air quality monitoring stations in the EU are covered by the model, including more than 400 traffic stations and 70% of the critical stations. Together with its well-established bottom-up emission and dispersion calculation scheme, GAINS is thus able to bridge the scales from European-wide policies to impacts in street canyons. As an application of the model, we assess the evolution of attainment of NO2 limit values under current legislation until 2030. Strong improvements are expected with the introduction of the Euro 6 emission standard for light duty vehicles; however, for some major European cities, further measures may be required, in particular if aiming to achieve compliance at an earlier time.

Legal regulation of the production and trade of medical devices and medical equipment in the EU and US: experience for Ukraine.

PubMed

Pashkov, Vitalii; Kotvitska, Alla; Harkusha, Andrii

2017-01-01

The need for effective legal regulation of production and sale of medical products in Ukraine due to its social effect is obvious and requires a high level of clarity. The experience of more advanced countries in this area, given the way chosen by Ukraine to harmonize our laws with EU legislation, is certainly could be a useful source of information. The urgency of issues need further intensification of national legal reforms. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. Legislation of Ukraine, European Union, United States of America, Guidelines, developed by European Commission & Food and Drug Administration's (FDA), recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. This study provide a possibility to state that main difference of regulatory systems in EU and US is that the legal framework of the EU is more flexible. This flexibility is grounded on main principle that only basic quality requirements for medical devices is defined by legislative acts however more detailed requirements are defined in standards, technical regulations, specifications, which are discretionary in nature. Contractors are free to choose any technical solution that provides compliance with the essential requirements, they can choose among different conformity assessment procedures and between accredited conformity assessment bodies to which they want to apply. The contractors themselves is interested to pass the conformity assessment procedure and have the right to put a conformity mark on their medical device because it will give them a real competitive advantage. In contrast, US State regulatory system provides strict control over business entities and law act establishes the quality requirements of medical products. The only body that can authorize the introduction of medical products and perform post-market monitoring is Food and Drug Administration (FDA), which has almost unlimited competence in this sphere. Taking into account further deepening of the European integration process of Ukraine, establishing of the regulatory system as much similar to that of the EU as possible is a main goal of legal reforms in abovementioned sphere. On the one hand, such system allows to implement effective control of contractors in the sphere of production and sale of medical products and provide safety of medical devices that are introduced, on the other hand, it does not afflict contractors with excessive and total control, allowing them to choose behavior that is most acceptable, understandable and user-specific. However, US's experience also has some positive characteristics, which could be taken into account. Therefore, such complex symbiosis of approaches from our point of view will balance controversial interest of manufacturers, sellers and consumers of medical devices.

“Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents

PubMed Central

Smith, Katherine E.; Fooks, Gary; Collin, Jeff; Weishaar, Heide; Mandal, Sema; Gilmore, Anna B.

2010-01-01

Background Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA. Methods and Findings In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost–benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health. Conclusions Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies. Please see later in the article for the Editors' Summary PMID:20084098

"Working the system"--British American tobacco's influence on the European union treaty and its implications for policy: an analysis of internal tobacco industry documents.

PubMed

Smith, Katherine E; Fooks, Gary; Collin, Jeff; Weishaar, Heide; Mandal, Sema; Gilmore, Anna B

2010-01-12

Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA. In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost-benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health. Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.

The new European legislation on traditional herbal medicines: main features and perspectives.

PubMed

Silano, Marco; De Vincenzi, Massimo; De Vincenzi, Alessandro; Silano, Vittorio

2004-03-01

Under the Italian Presidency of the Council of the European Union (July 2003-December 2003) an agreement has been reached by the European Parliament and the Council on the approval of the proposal of Directive of the European Parliament and the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products. Once implemented in the E.U. Member States, this new Directive will remove the constraints that have made it difficult granting marketing authorisations of herbal substances and preparations as traditional medicinal products under the pre-existing Community legislation. The main features (i.e. traditional herbal medicine definition, simplified registration procedure, provisions for Community herbal monographs and Community list of herbal substances and preparations and establishment of the Committee for Herbal Medicinal Products) of this new Community legislation are analysed and discussed in the present paper together with some expected positive public health impacts.

Recent changes in Danish law on drugs and drug offences.

PubMed

Jepsen, J; Laursen, L

1998-09-01

The article recounts changes in Danish Drug Law and Enforcement since the beginning of the 1990s and relates them to general trends in Danish criminal policy during the period. In addition to the implementation of EU directives, e.g. on money laundering and growth hormones, legislation has been passed to curb conspicuous dealing of drugs in the streets of Copenhagen. This part of the legislation is seen as a reaction to public fears and reactions to visible aliens dealing in drugs in a conspicuous way, albeit in minor quantities. The legal changes imply a considerable rise in penalties for repeated dealings in minor quantities and easier access to deportation of aliens. The latter has been criticized as potential violation of the human rights of aliens. This and other recent changes in criminal law and related legislation is seen as an indication of politicians' concerns with voters' anxieties, possibly at the edge of moral panics.

Recognition of pharmaceutical prescriptions across the European Union: a comparison of five Member States' policies and practices.

PubMed

Miguel, Lorena San; Augustin, Uta; Busse, Reinhard; Knai, Cécile; Rubert, Gloria; Sihvo, Sinikka; Baeten, Rita

2014-06-01

In 2011, the EU Directive on Patients' Rights in Cross Border Healthcare was approved, including a regulation on mutual recognition of prescriptions. To compare current national policies and practices on prescribing and dispensing, prescription-only medicines (POMs) in European countries in order to identify differences which could, challenge acceptance across borders. Semi-structured interviews with 37 national stakeholders were carried out. Furthermore, data on policies for prescribing and dispensing POMs were gathered based on desk research, and, contacts with relevant authorities via a purposely designed questionnaire. Important differences exist regarding: (1) information requirements for prescriptions to be, legally valid, (2) generic and international non-proprietary name (INN) policies and (3) professionals, legally allowed to prescribe POMs. Moreover, there is a lack of EU-wide access to key information for, validating prescriptions, recognizing the equivalence of products or identifying authorised prescribers. Differences in legislation and its application across Europe pose important challenges to be, addressed by policy makers with appropriate actions: (1) a prescribed product may not be dispensed, to a patient who needs it, (2) an inappropriate product (or inappropriate instructions) could be, provided and (3) POMs could be dispensed and consumed or sold, based on false prescriptions. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Municipal solid waste development phases: Evidence from EU27.

PubMed

Vujić, Goran; Gonzalez-Roof, Alvaro; Stanisavljević, Nemanja; Ragossnig, Arne M

2015-12-01

Many countries in the European Union (EU) have very developed waste management systems. Some of its members have managed to reduce their landfilled waste to values close to zero during the last decade. Thus, European Union legislation is very stringent regarding waste management for their members and candidate countries, too. This raises the following questions: Is it possible for developing and developed countries to comply with the European Union waste legislation, and under what conditions? How did waste management develop in relation to the economic development in the countries of the European Union? The correlation between waste management practices and economic development was analysed for 27 of the European Union Member States for the time period between 1995 and 2007. In addition, a regression analysis was performed to estimate landfilling of waste in relation to gross domestic product for every country. The results showed a strong correlation between the waste management variables and the gross domestic product of the EU27 members. The definition of the municipal solid waste management development phases followed a closer analysis of the relation between gross domestic product and landfilled waste. The municipal solid waste management phases are characterised by high landfilling rates at low gross domestic product levels, and landfilling rates near zero at high gross domestic product levels. Hence the results emphasize the importance of wider understanding of what is required for developing countries to comply with the European Union initiatives, and highlight the importance of allowing developing countries to make their own paths of waste management development. © The Author(s) 2015.

Will the European Union's new tobacco tax legislation lead to reductions in smoking prevalence? Evidence from a quasi-experiment in Spain.

PubMed

López-Nicolás, Angel; Badillo-Amador, Lourdes; Cobacho-Tornel, M Belén

2013-12-01

The European Union (EU) requires member states to apply minimum taxes on manufactured cigarettes. One such tax has operated in Spain since 2006. This study evaluates the impact of this reform of the tax regime on manufactured cigarette prices and on smoking prevalence, drawing implications for European tobacco tax policy. Quasi-experimental design with treatment and control territories. We analyzed series for prices before and after the reform and used cross-sectional health surveys to implement differences-in-differences estimators for smoking prevalence. Under the minimum tax regime, prices increased three times faster in the treatment territory. However, the new regime did not affect smoking prevalence among males, either shortly after its enactment or 3 years hence. For women, we find no significant effects on prevalence in the short run, and point estimates ranging between -3.36% and -4.3% 3 years hence, although only one of these is statistically significant. The new tax regime affected cigarette prices in the intended direction. However, we find only weak evidence for a reduction in prevalence among women. The availability of cheap, fine-cut tobacco appears to be the most likely cause for the poor results in terms of smoking prevalence. EU member states that have introduced a minimum tax on manufactured cigarettes might achieve little in terms of reductions in smoking prevalence if they allow a tax gap between fine-cut tobacco and manufactured cigarettes. In this sense, it is unfortunate that EU legislation consecrates a differential treatment for the two products.

European Energy Policy and Its Effects on Gas Security

NASA Astrophysics Data System (ADS)

Radu, Victorita Stefana Anda

The goal of this study is to examine the effects of the energy policies of the European Union (EU) on its gas security in the period 2006 to 2016. While energy security is often given a broad meaning, this paper focuses on its external dimension: the EU?s relations with external gas suppliers. It is grounded on four pillars drawing from the compounded institutionalist and liberal theoretical frameworks: regulatory state, rational-choice, external governance, and regime effectiveness. The research question was investigated through a qualitative methodology with two main components: a legislative analysis and four case studies representing the main gas supply options--Russia, North African exporting countries, Norway, and liquefied natural gas (LNG). They highlighted that the EU framed the need for gas security mainly in the context of political risks associated with Russian gas supply, but it almost never took into account other equally important risks. Moreover, the research revealed two main issues. First, that the deeper and the more numerous EU?s energy policies were, the bigger was the magnitude of the effect. Specifically, competitiveness and infrastructure policies had the largest magnitude, while the sustainability and security of supply policies had the smallest effect. Second, EU energy policies only partially diminished the economic and political risks in relation to foreign gas suppliers. To conclude, to a certain extent the EU?s efforts made a positive contribution to the external dimension of the EU?s gas security, but the distinguishing trait remains that there is no consistency in terms of the magnitude of the effect and its nature.

Food additives used in meat processing according to the Polish and European Union legislation.

PubMed

Uradziński, J; Weiner, M

2003-01-01

This paper presents the legal regulations related to the use of food additives in meat production in Poland and the European Union. The Polish legal definition of food additives is given as well as the classification of permitted food additives added to food and stimulants by their technological function. In addition, a definition of processing aids in the food industry is included. It shows that Polish legislation includes food additives used to ensure or improve food nutritional value, whereas in the EU legislation, these substances are not included in the list of food additives. Moreover, the Council Directives include food additive specific purity criteria, whereas the Polish regulations do not mention the legal regulations of this issue in practice. The European Union use mechanisms and procedures for the introduction of new food additives into internal markets as well as controlling the circulation of additives. The Polish legislation in practice, however, does not determine approval or methods for the introduction of new food additives to the market. Legal regulations on the monitoring of food additives no exist.

Stakeholder involvement for management of the coastal zone.

PubMed

Oen, Amy Mp; Bouma, Geiske M; Botelho, Maria; Pereira, Patrícia; Haeger-Eugensson, Marie; Conides, Alexis; Przedrzymirska, Joanna; Isaksson, Ingela; Wolf, Christina; Breedveld, Gijs D; Slob, Adriaan

2016-10-01

The European Union (EU) has taken the lead to promote the management of coastal systems. Management strategies are implemented by the Water Framework Directive (WFD) and the Marine Strategy Framework Directive (MSFD), as well as the recent Maritime Spatial Planning (MSP) Directive. Most EU directives have a strong focus on public participation; however, a recent review found that the actual involvement of stakeholders was variable. The "Architecture and roadmap to manage multiple pressures on lagoons" (ARCH) research project has developed and implemented participative methodologies at different case study sites throughout Europe. These cases represent a broad range of coastal systems, and they highlight different legislative frameworks that are relevant for coastal zone management. Stakeholder participation processes were subsequently evaluated at 3 case study sites in order to assess the actual implementation of participation in the context of their respective legislative frameworks: 1) Byfjorden in Bergen, Norway, in the context of the WFD; 2) Amvrakikos Gulf, Greece, in the context of the MSFD; and 3) Nordre Älv Estuary, Sweden, in the context of the MSP Directive. An overall assessment of the evaluation criteria indicates that the ARCH workshop series methodology of focusing first on the current status of the lagoon or estuary, then on future challenges, and finally on identifying management solutions provided a platform that was conducive for stakeholder participation. Results suggest that key criteria for a good participatory process were present and above average at the 3 case study sites. The results also indicate that the active engagement that was initiated at the 3 case study sites has led to capacity building among the participants, which is an important intermediary outcome of public participation. A strong connection between participatory processes and policy can ensure the legacy of the intermediary outcomes, which is an important and necessary start toward more permanent resource management outcomes such as ecological and economic improvement. Integr Environ Assess Manag 2016;12:701-710. © 2016 SETAC. © 2016 SETAC.

Gas chromatography coupled to tunable pulsed glow discharge time-of-flight mass spectrometry for environmental analysis.

PubMed

Solà-Vázquez, Auristela; Lara-Gonzalo, Azucena; Costa-Fernández, José M; Pereiro, Rosario; Sanz-Medel, Alfredo

2010-05-01

A tuneable microsecond pulsed direct current glow discharge (GD)-time-of-flight mass spectrometer MS(TOF) developed in our laboratory was coupled to a gas chromatograph (GC) to obtain sequential collection of the mass spectra, at different temporal regimes occurring in the GD pulses, during elution of the analytes. The capabilities of this set-up were explored using a mixture of volatile organic compounds of environmental concern: BrClCH, Cl(3)CH, Cl(4)C, BrCl(2)CH, Br(2)ClCH, Br(3)CH. The experimental parameters of the GC-pulsed GD-MS(TOF) prototype were optimized in order to separate appropriately and analyze the six selected organic compounds, and two GC carrier gases, helium and nitrogen, were evaluated. Mass spectra for all analytes were obtained in the prepeak, plateau and afterpeak temporal regimes of the pulsed GD. Results showed that helium offered the best elemental sensitivity, while nitrogen provided higher signal intensities for fragments and molecular peaks. The analytical performance characteristics were also worked out for each analyte. Absolute detection limits obtained were in the order of ng. In a second step, headspace solid phase microextraction (HS SPME), as sample preparation and preconcentration technique, was evaluated for the quantification of the compounds under study, in order to achieve the required analytical sensitivity for trihalomethanes European Union (EU) environmental legislation. The analytical figures of merit obtained using the proposed methodology showed rather good detection limits (between 2 and 13 microg L(-1) depending on the analyte). In fact, the developed methodology met the EU legislation requirements (the maximum level permitted in tap water for the "total trihalomethanes" is set at 100 microg L(-1)). Real analysis of drinking water and river water were successfully carried out. To our knowledge this is the first application of GC-pulsed GD-MS(TOF) for the analysis of real samples. Its ability to provide elemental, fragments and molecular information of the organic compounds is demonstrated.

Retrospective analysis of the mutagenicity/genotoxicity data of the cosmetic ingredients present on the Annexes of the Cosmetic EU legislation (2000-12).

PubMed

Ates, Gamze; Doktorova, Tatyana Y; Pauwels, Marleen; Rogiers, Vera

2014-03-01

To evaluate the mutagenicity/genotoxicity of cosmetic ingredients at the regulatory level, usually a battery of three in vitro tests is applied. This battery, designed to be very sensitive, produces a high number of positive results, imposing the need for in vivo follow-up testing to clear the substance under study. In Europe, the use of experimental animals has become impossible for cosmetic ingredients due to the implementation of animal testing and marketing bans. Consequently, the possibility to 'de-risk' substances with positive in vitro results disappear and potentially safe cosmetic substances will be lost for the EU market unless currently used in vitro assays can be adapted or new non-animal mutagenicity/genotoxicity studies become available. Described strategies to improve the specificity of existing in vitro assays include optimisation of the used cell type and cytotoxicity assay and lowering of the applied top concentration. A reduction of the number of tests in the battery from three to two also has been suggested. In this study, the performance of the 'standard' in vitro mutagenicity/genotoxicity testing battery is analysed for a number of cosmetic ingredients. We composed a database with toxicological information on 249 cosmetic ingredients, mainly present on the Annexes of the European cosmetic legislation. Results revealed that the in vitro mutagenicity/genotoxicity tests showed a low specificity for the cosmetic ingredients concerned, comparable to the specificity published for chemicals. Non-confirmed or 'misleading' positive results amounted up to 93% for the in vitro test batteries. The cell type and top concentrations did not have a major impact on the specificity. With respect to cytotoxicity determinations, different end points were used, potentially leading to different testing concentrations, suggesting the need for a consensus in this matter. Overall, the results of this retrospective analysis point to an urgent need of better regulatory strategies to assess the potential mutagenicity/genotoxicity of cosmetic ingredients.

Air quality improvements using European environment policies: a case study of SO2 in a coastal region in Portugal.

PubMed

Pereira, M C; Santos, R C; Alvim-Ferraz, M C M

2007-02-01

The European Union (EU) has defined several efforts for preventing and controlling air pollution that have led to a generalized reduction of health risks and environmental effects. One example of these efforts was the establishment of legislation that imposed a reduction of sulfur content in fuels, switching to cleaner fuels for industry and motor vehicles (Auto-Oil Directives). The goal of this study was to evaluate the first trends in the air quality of Oporto Metropolitan Area (Oporto-MA) related to implementation of these directives in Portugal since 2000. Therefore, sulfur dioxide (SO2) concentration data from air quality monitoring sites were analyzed for the period 1999 through 2003. It was observed that daily SO2 concentrations in the industrial area are much higher than those of the urban and rural areas, reflecting the influence of the industrial sector. The annual SO2 concentrations for the consecutive years of analysis decreased considerably for all the monitoring sites. A considerable decrease in SO2 emissions was also observed for the same period. According to EU legislation, the exceedances of the SO2 recommended limit values decreased significantly. In conclusion, this analysis shows evidence that SO2 concentrations are decreasing, and that this is consistent with the implementation of the legislation and control of the sources of pollution. Nevertheless, the potential for human health risks still persists, particularly in industrialized areas. It is expected that SO2 concentration levels in ambient air of Oporto-MA will continue to decrease in the coming years, following the present European trends.

Will the Eu Data Protection Regulation 2016/679 Inhibit Critical Care Research?

PubMed

Timmers, Marjolein; Van Veen, Evert-Ben; Maas, Andrew I R; Kompanje, Erwin J O

2018-05-17

There is an inherent tension between critical care research and data protection. Because of their condition it is not possible to ask for the patients' informed consent to be enrolled in observational research at the point of admission to the hospital. Often this is not possible at a later moment either. Yet informed consent is the baseline to be enrolled in research with personal data and exceptions must be allowed for by national legislation. This was the case under Directive 95/96/EC and will be the case under the General Data Protection Regulation (GDPR, Regulation 2016/679 EU) which will replace the Directive from 25 May 2018 onwards. Though being a Regulation and therefore directly applicable in the Member States, the long debate about the research exceptions in the GDPR left many aspects of observational research including the exception to the informed consent principle, mainly to the Member States. It may be assumed that most Member States will leave their present state of the law intact in this respect as that was part of the political compromise. We compared existing national privacy legislation from the perspective of critical care research and found great variation. Although this may not impede the collection of emergency and critical care research with data without prior informed consent in countries which are more responsive to such research, it might be a challenge to exchange such data from the national nodes in European wide research collaboration. We make a case that countries which are not responsive to such research should adapt their legislation in the interests of future critical care patients.

[Health policy in the European Union: impact on the Spanish health system].

PubMed

Guimarães, Luisa; Freire, José-Manuel

2007-01-01

This text reviews the impact of European integration on the health sector (public health and health services) by studying European Union (EU) institutions, functioning, and responsibilities through the literature, documents, and authors' observations. The EU does not have direct health responsibilities, but Community legislation has important repercussions on all member states' health policies. This influence affects health protection issues, consumer safety, regulation of medicines and medical devices, mutual recognition of professional qualifications, freedom of movement for health professionals and patients, public contracts and bidding, research, etc. The evolution of EU health policy shows a progressive reinforcement of responsibilities consistent with the objective of reaching a high level of health protection, which in turn affects other European policies. The impact of European integration on the Spanish health system is analyzed as a case study, and key aspects and present and future challenges are highlighted. Lessons are also drawn for regional integration processes to foster equity and efficiency in health.

Asbestos Utilization Costs on the Example of Functioning Landfill of Hazardous Waste

NASA Astrophysics Data System (ADS)

Polek, Daria

2017-12-01

Asbestos is a trademark of mineral fibres, which are the natural minerals found in nature. Products containing asbestos fibres, in accordance with the national and EU legislation, are covered by the production prohibition and forced to be removed. In Poland, the asbestos removal process started with the adaptation of the EU law by the Council of Ministers Treatment Program of the National Asbestos for the years 2009-2032. The purpose of the dissertation was to analyse the costs associated with the disposal of the costs of collection, transport and disposal of waste. Methodology consisted in obtaining information on the raw materials needed to produce asbestos sheets. The analysis allowed us to determine the asbestos removal cost and include state subsidies in the calculations.

Possibility to implement invasive species control in Swedish forests.

PubMed

Pettersson, Maria; Strömberg, Caroline; Keskitalo, E Carina H

2016-02-01

Invasive alien species constitute an increasing risk to forestry, as indeed to natural systems in general. This study reviews the legislative framework governing invasive species in the EU and Sweden, drawing upon both a legal analysis and interviews with main national level agencies responsible for implementing this framework. The study concludes that EU and Sweden are limited in how well they can act on invasive species, in particular because of the weak interpretation of the precautionary principle in the World Trade Organisation and Sanitary and Phytosanitary agreements. In the Swedish case, this interpretation also conflicts with the stronger interpretation of the precautionary principle under the Swedish Environmental Code, which could in itself provide for stronger possibilities to act on invasive species.

Evaluating the ethical acceptability of animal research.

PubMed

Bout, Henriëtte J; Fentener van Vlissingen, J Martje; Karssing, Edgar D

2014-11-01

The ethical acceptability of animal research is typically evaluated on a case-by-case basis. Legislation such as Directive 2010/63/EU on the protection of animals used for scientific purposes provides guidance for ethical evaluation of animal use proposals but does not dictate the outcome, leaving this determination to the ethical review committees of individual institutions. The authors assess different ethics models and how these are reflected in the guidelines of Directive 2010/63/EU. They also describe a matrix for carrying out harm-benefit analyses of animal use proposals, which they identified by examining the practices of three ethical review committees in the Netherlands. Finally, they discuss how this matrix can be applied by ethical review committees at other institutions.

Public banking of umbilical cord blood or storage in a private bank: testing social and ethical policy in northeastern Italy

PubMed Central

Parco, Sergio; Vascotto, Fulvia; Visconti, Patrizia

2013-01-01

Background In northeastern Italy, according to Italian legislation, authorized public facilities can accept the donation and preservation of cord blood stem cells (CB-SC). Attitudes and knowledge in pregnant women differs between the local and immigrant (non-European Union [EU]) population. In this study we assessed the choices that pregnant women have with respect to the public and private harvesting system and the main reasons driving their decisions. We examined the ethnic origin of the families and compared tests for syphilis screening and leukocyte (WBC) counts in the CB-SC bags that are required for validation of the collection. Methods Out of a population of 3450 pregnant patients at the Institute for Maternal and Child Health of Trieste, northeast Italy, 772 women agreed to cord blood harvesting and the associated lab tests. Of these, 221 women (28.6%) were from immigrant families of non-EU countries. Their ethnic affiliation was recorded, and tests were performed for syphilis screening and for nucleated red blood cell (NRBC) interference with the WBC count in CB-SC bags to assess cellularity and to determine if storage was appropriate. Results Of the 772 pregnant women, 648 (84.0%) accessed the public collection system, which is free of charge, and 124 (15.0%) accessed the private fee-based system. One woman from the non-EU group opted for the private fee-based system. Of the 3450 pregnant women screened for syphilis at the Institute for Maternal and Child Health, the Treponema pallidum hemagglutination (TPHA) and Venereal Disease Research Laboratory (VDRL) tests were the main tests performed (66.0% of total cases) because many gynecologists in the public harvesting system apply the Italian regulations of the 1988 Decree, while the private system requires tests on syphilis and leaves the option to the lab physicians to select the best determination method. We found that the chemiluminescence method was more specific (97.0%) than the TPHA (83.0%) and nontreponemal rapid plasma reagin VDRL (75.0%) tests (P < 0.05, χ2 test). The specificity link between the two automatic methods versus microscopes for WBC dosing and NRBC interference was r2 = 0.08 (ADVIA 120) and r2 = 0.94 (XE-2100). The public system does not include human T-cell lymphotropic virus testing; this is reserved for the population from endemic zones. Conclusion In northeastern Italy current legislation prevents the establishment of private fee-based banks for storage of CB-SC. The cryopreservation, for future autologous personal or family use, is possible only by sending to foreign private banks, with a further fee of €300. These regulations confirm that Italian legislation tries to increase the anonymous allogenic donations and the number of CB-CS bags stored in the free-cost public system, that are available to anyone with therapeutic needs. Private banking is used almost exclusively by the wealthier local population. In the public system, many physicians continue to use older Italian laws regarding syphilis diagnosis, and NRBC interference on WBC count may have an impact on cord blood harvesting. Our findings suggest that in the EU there is no consensus policy on donor management. The value of storage for potential use within the family is useful only with collaboration between the public and the private systems. PMID:23610532

Public banking of umbilical cord blood or storage in a private bank: testing social and ethical policy in northeastern Italy.

PubMed

Parco, Sergio; Vascotto, Fulvia; Visconti, Patrizia

2013-01-01

In northeastern Italy, according to Italian legislation, authorized public facilities can accept the donation and preservation of cord blood stem cells (CB-SC). Attitudes and knowledge in pregnant women differs between the local and immigrant (non-European Union [EU]) population. In this study we assessed the choices that pregnant women have with respect to the public and private harvesting system and the main reasons driving their decisions. We examined the ethnic origin of the families and compared tests for syphilis screening and leukocyte (WBC) counts in the CB-SC bags that are required for validation of the collection. Out of a population of 3450 pregnant patients at the Institute for Maternal and Child Health of Trieste, northeast Italy, 772 women agreed to cord blood harvesting and the associated lab tests. Of these, 221 women (28.6%) were from immigrant families of non-EU countries. Their ethnic affiliation was recorded, and tests were performed for syphilis screening and for nucleated red blood cell (NRBC) interference with the WBC count in CB-SC bags to assess cellularity and to determine if storage was appropriate. Of the 772 pregnant women, 648 (84.0%) accessed the public collection system, which is free of charge, and 124 (15.0%) accessed the private fee-based system. One woman from the non-EU group opted for the private fee-based system. Of the 3450 pregnant women screened for syphilis at the Institute for Maternal and Child Health, the Treponema pallidum hemagglutination (TPHA) and Venereal Disease Research Laboratory (VDRL) tests were the main tests performed (66.0% of total cases) because many gynecologists in the public harvesting system apply the Italian regulations of the 1988 Decree, while the private system requires tests on syphilis and leaves the option to the lab physicians to select the best determination method. We found that the chemiluminescence method was more specific (97.0%) than the TPHA (83.0%) and nontreponemal rapid plasma reagin VDRL (75.0%) tests (P < 0.05, χ(2) test). The specificity link between the two automatic methods versus microscopes for WBC dosing and NRBC interference was r(2) = 0.08 (ADVIA 120) and r(2) = 0.94 (XE-2100). The public system does not include human T-cell lymphotropic virus testing; this is reserved for the population from endemic zones. In northeastern Italy current legislation prevents the establishment of private fee-based banks for storage of CB-SC. The cryopreservation, for future autologous personal or family use, is possible only by sending to foreign private banks, with a further fee of €300. These regulations confirm that Italian legislation tries to increase the anonymous allogenic donations and the number of CB-CS bags stored in the free-cost public system, that are available to anyone with therapeutic needs. Private banking is used almost exclusively by the wealthier local population. In the public system, many physicians continue to use older Italian laws regarding syphilis diagnosis, and NRBC interference on WBC count may have an impact on cord blood harvesting. Our findings suggest that in the EU there is no consensus policy on donor management. The value of storage for potential use within the family is useful only with collaboration between the public and the private systems.

Attitudes regarding the national forensic DNA database: Survey data from the general public, prison inmates and prosecutors' offices in the Republic of Serbia.

PubMed

Teodorović, Smilja; Mijović, Dragan; Radovanović Nenadić, Una; Savić, Marina

2017-05-01

Worldwide, the establishment of national forensic DNA databases has transformed personal identification in the criminal justice system over the past two decades. It has also stimulated much debate centering on ethical issues, human rights, individual privacy, lack of safeguards and other standards. Therefore, a balance between effectiveness and intrusiveness of a national DNA repository is an imperative and needs to be achieved through a suitable legal framework. On its path to the European Union (EU), the Republic of Serbia is required to harmonize its national policies and legislation with the EU. Specifically, Chapter 24 of the EU acquis communautaire (Justice, Freedom and Security) stipulates the compulsory creation of a forensic DNA registry and adoption of corresponding legislation. This process is expected to occur in 2016. Thus, in light of launching the national DNA database, the goal of this work is to instigate a consultation with the Serbian public regarding their views on various aspects of the forensic DNA databank. Importantly, this study specifically assessed the opinions of distinct categories of citizens, including the general public, the prosecutors' offices staff, prisoners, prison guards, and students majoring in criminalistics. Our findings set a baseline for Serbian attitudes towards DNA databank custody, DNA sample and profile inclusion and retention criteria, ethical issues and concerns. Furthermore, results clearly demonstrate a permissive outlook of the respondents who are professional "beneficiaries" of genetic profiling and a restrictive position taken by the respondents whose genetic material has been acquired by the government. We believe that this opinion poll will be essential in discussions regarding a national DNA database, as well as in motivating further research on the reasons behind the observed views and subsequent development of educational strategies. All of these are, in turn, expected to aid the creation of suitable legislation and to increase societal confidence that the repository will be used in the legal system without interference with individual rights and freedoms. Copyright © 2017 Elsevier B.V. All rights reserved.

Current healthcare in Bulgaria: time for predictive diagnostics and preventive medicine.

PubMed

Dimitrov, Dimiter V

2010-12-01

Since 1990 Bulgaria gradually moved from monopolistic to market regulated economy and healthcare. In 2007 the country became member of the European Union and started to adopt EU legislations. However, significant gaps between the average European and Bulgarian level of social, health and economic efficiency remain to be narrowed. The major challenge is the demographic situation, where recent trends give alarming signals. Plans for reformation include transition towards out-patient palliative healthcare centers for the aging population as well as reduction of the costs with new electronic system of health insurance. The favorable location of the country at the Black Sea coast gives opportunities for medical tourism, which can provide quality health service for foreign customers. Finally, national platforms on prevention of major non-communicable diseases, such as obesity, cancer and diabetes, must be established as coordinated actions for the health and wellness of next generations.

Comments on pesticide risk assessment by the revision of Directive EU 91/414.

PubMed

Balderacchi, Matteo; Trevisan, Marco

2010-03-01

Human health and the environment are major concerns for European Commission policy on the authorisation of plant protection products. The new regulation that revises and replaces the directive 91/414/EC moves towards the adoption of a Persistent Bioaccumulation Toxicity cutoff criterion because current pesticide risk assessment (PRA) is deterministic, based on few standard cases and therefore characterised by uncertainty. This revision could create concerns about sustainability. This paper analyses some effects of this directive on the agrochemical market and assumes new effects resulting from the introduction of the revision. Suggestions are made as to how pesticide risk assessment will have to adapt to answer the request of legislators on safety standards and sustainability, introducing probabilistic PRA. Toxicity and exposure functions will be fully characterised, producing distributions of predicted impact and quantifying the variability and uncertainty. For adopting PRA studies at the local/catchment scale, new assessment schemes will be necessary.

A conceptual framework for the design of environmental post-market monitoring of genetically modified plants.

PubMed

Sanvido, Olivier; Widmer, Franco; Winzeler, Michael; Bigler, Franz

2005-01-01

Genetically modified plants (GMPs) may soon be cultivated commercially in several member countries of the European Union (EU). According to EU Directive 2001/18/EC, post-market monitoring (PMM) for commercial GMP cultivation must be implemented, in order to detect and prevent adverse effects on human health and the environment. However, no general PMM strategies for GMP cultivation have been established so far. We present a conceptual framework for the design of environmental PMM for GMP cultivation based on current EU legislation and common risk analysis procedures. We have established a comprehensive structure of the GMP approval process, consisting of pre-market risk assessment (PMRA) as well as PMM. Both programs can be distinguished conceptually due to principles inherent to risk analysis procedures. The design of PMM programs should take into account the knowledge gained during approval for commercialization of a specific GMP and the decisions made in the environmental risk assessments (ERAs). PMM is composed of case-specific monitoring (CSM) and general surveillance. CSM focuses on anticipated effects of a specific GMP. Selection of case-specific indicators for detection of ecological exposure and effects, as well as definition of effect sizes, are important for CSM. General surveillance is designed to detect unanticipated effects on general safeguard subjects, such as natural resources, which must not be adversely affected by human activities like GMP cultivation. We have identified clear conceptual differences between CSM and general surveillance, and propose to adopt separate frameworks when developing either of the two programs. Common to both programs is the need to put a value on possible ecological effects of GMP cultivation. The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization.

Bovine tuberculosis surveillance in cattle and free-ranging wildlife in EU Member States in 2013: a survey-based review.

PubMed

Rivière, J; Carabin, K; Le Strat, Y; Hendrikx, P; Dufour, B

2014-10-10

Bovine tuberculosis (TB) is a common disease in cattle and wildlife, with animal health, zoonotic and economic impacts. Most of the TB data for the European Union (EU) concern the epidemiological situation, but comprehensive descriptions of the way in which surveillance is conducted in each country are rare, despite being essential for cross-Europe comparisons. A European survey was conducted in the 28 Member States and in three other neighboring countries (Norway, Macedonia and Switzerland), to review TB surveillance in cattle and wildlife. EU legislation currently requires TB surveillance solely in cattle. Considerable differences between the surveillance systems of the 26 responding countries were observed, according to the official TB-freedom status of the country and the local prevalence of TB. These differences related principally to the combination of surveillance components (routine screening test in herd and/or movement testing and/or slaughterhouse surveillance), the tests used and their interpretation, and the definition of an infected herd or animal. For wildlife TB surveillance, only 8 on 21 respondent countries have declared to have implemented passive and/or active surveillance, with marked differences concerning the species and the geographical scale of the surveillance. The choice of the combination of surveillance components depends on the national or regional epidemiological situation, the species involved in TB epidemiology and epidemiological risk factors, although various surveillance systems have been recorded for countries with similar epidemiological status. Assessments of the cost-effectiveness of each surveillance system would be useful, to confirm the advantages of implementing one or more components. Copyright © 2014 Elsevier B.V. All rights reserved.

10 Years of Native Seed Certification in Germany - a Summary.

PubMed

Mainz, Ann Kareen; Wieden, Markus

2018-06-21

Many renaturation projects and compensation areas are based on the use of seeds from regional indigenous wild plants, in the following: native or regional seeds. Despite this, such seeds make up only a small proportion of the total number of seeds used for greening projects - in Germany, for example, it is only around 1% (= 200 t/yr). Although the market for regional seeds is small, it is highly competitive. High-priced native seeds compete with flower mixes of unspecified origin and can only be differentiated from them by reliable quality seals. A quality assurance system based on seed legislation (EU Directive 2010/60, preservation mixtures) has been developed in a few European countries. However, quality assurance ends with the sale of the seeds. Thus, seed use remains unmonitored and often unsuitable material, or material foreign to the region, is planted in restoration areas. Unfortunately, nature conservation has not made seed-based restoration one of its key issues, neither at the European, nor at the national level. Currently there are many different local and regional standards, methods and private certificates that are confusing for users and which provide little continuity and predictability for producers. We recommend the establishment of an EU directive or a broadly agreed recommendation to the EU member states, spearheaded by nature conservation, which would define the standards for producing and using native seeds (e.g. harmonized regions that cross national borders, quality regulations). At the same time, wild plant interest groups should combine existing structures in order to strengthen seed-based restoration through international cooperation. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A case study of polypharmacy management in nine European countries: Implications for change management and implementation.

PubMed

McIntosh, Jennifer; Alonso, Albert; MacLure, Katie; Stewart, Derek; Kempen, Thomas; Mair, Alpana; Castel-Branco, Margarida; Codina, Carles; Fernandez-Llimos, Fernando; Fleming, Glenda; Gennimata, Dimitra; Gillespie, Ulrika; Harrison, Cathy; Illario, Maddalena; Junius-Walker, Ulrike; Kampolis, Christos F; Kardas, Przemyslaw; Lewek, Pawel; Malva, João; Menditto, Enrica; Scullin, Claire; Wiese, Birgitt

2018-01-01

Multimorbidity and its associated polypharmacy contribute to an increase in adverse drug events, hospitalizations, and healthcare spending. This study aimed to address: what exists regarding polypharmacy management in the European Union (EU); why programs were, or were not, developed; and, how identified initiatives were developed, implemented, and sustained. Change management principles (Kotter) and normalization process theory (NPT) informed data collection and analysis. Nine case studies were conducted in eight EU countries: Germany (Lower Saxony), Greece, Italy (Campania), Poland, Portugal, Spain (Catalonia), Sweden (Uppsala), and the United Kingdom (Northern Ireland and Scotland). The workflow included a review of country/region specific polypharmacy policies, key informant interviews with stakeholders involved in policy development and implementation and, focus groups of clinicians and managers. Data were analyzed using thematic analysis of individual cases and framework analysis across cases. Polypharmacy initiatives were identified in five regions (Catalonia, Lower Saxony, Northern Ireland, Scotland, and Uppsala) and included all care settings. There was agreement, even in cases without initiatives, that polypharmacy is a significant issue to address. Common themes regarding the development and implementation of polypharmacy management initiatives were: locally adapted solutions, organizational culture supporting innovation and teamwork, adequate workforce training, multidisciplinary teams, changes in workflow, redefinition of roles and responsibilities of professionals, policies and legislation supporting the initiative, and data management and information and communication systems to assist development and implementation. Depending on the setting, these were considered either facilitators or barriers to implementation. Within the studied EU countries, polypharmacy management was not widely addressed. These results highlight the importance of change management and theory-based implementation strategies, and provide examples of polypharmacy management initiatives that can assist managers and policymakers in developing new programs or scaling up existing ones, particularly in places currently lacking such initiatives.

The changes in hazard classification and product notification procedures of the new European CLP and Cosmetics Regulations.

PubMed

de Groot, Ronald; Brekelmans, Pieter; Herremans, Joke; Meulenbelt, Jan

2010-01-01

The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS) is developed to harmonize the criteria for hazard communication worldwide. The European Regulation on classification, labeling, and packaging of substances and mixtures [CLP Regulation (European Commission, EC) No 1272/2008] will align the existing European Union (EU) legislation to the UN-GHS. This CLP Regulation entered into force on January 20, 2009, and will, after a transitional period, replace the current rules on classification, labeling, and packaging for supply and use in Europe. Both old and new classifications will exist simultaneously until 2010 for substances and until 2015 for mixtures. The new hazard classification will introduce new health hazard classes and categories, with associated new hazard pictograms, signal words, Hazard (H)-statements, and Precautionary (P)-statements as labeling elements. Furthermore, the CLP Regulation will affect the notification of product information on hazardous products to poisons information centers (PICs). At this moment product notification widely varies in procedures and requirements across EU Member States. Article 45 of the CLP Regulation contains a provision stating that the EC will (by January 20, 2012) review the possibility of harmonizing product notification. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) is recognized as an important stakeholder. For cosmetic products, the new Cosmetics Regulation will directly implement a new procedure for electronic cosmetic product notification in all EU Member States. Both the CLP Regulation and the Cosmetics Regulation will develop their own product notification procedure within different time frames. Harmonization of notification procedures for both product groups, especially a common electronic format, would be most effective from a cost-benefit viewpoint and would be welcomed by PICs.

Evidence of natural occurrence of the banned antibiotic chloramphenicol in herbs and grass.

PubMed

Berendsen, Bjorn; Stolker, Linda; de Jong, Jacob; Nielen, Michel; Tserendorj, Enkhtuya; Sodnomdarjaa, Ruuragchas; Cannavan, Andrew; Elliott, Christopher

2010-07-01

Chloramphenicol (CAP), a broad-spectrum antibiotic, was detected in several herb and grass samples from different geographic origins. Due to its suspected carcinogenicity and linkages with the development of aplastic anemia in humans, CAP is banned for use in food-producing animals in the European Union (EU) and many other countries. However, products of animal origin originating from Asian countries entering the European market are still found noncompliant (containing CAP) on a regular basis, even when there is no history of chloramphenicol use in these countries. A possible explanation for the continued detection of these residues is the natural occurrence of CAP in plant material which is used as animal feed, with the consequent transfer of the substance to the animal tissues. Approximately 110 samples were analyzed using liquid chromatography coupled with mass spectrometric detection. In 26 samples, the presence of CAP was confirmed using the criteria for banned substances defined by the EU. Among other plant materials, samples of the Artemisia family retrieved from Mongolia and from Utah, USA, and a therapeutic herb mixture obtained from local stores in the Netherlands proved to contain CAP at levels ranging from 0.1 to 450 microg/kg. These findings may have a major impact in relation to international trade and safety to the consumer. The results of this study demonstrate that noncompliant findings in animal-derived food products may in part be due to the natural occurrence of chloramphenicol in plant material. This has implications for the application of current EU, USA, and other legislation and the interpretation of analytical results with respect to the consideration of CAP as a xenobiotic veterinary drug residue and the regulatory actions taken upon its detection in food.

Construction and demolition waste indicators.

PubMed

Mália, Miguel; de Brito, Jorge; Pinheiro, Manuel Duarte; Bravo, Miguel

2013-03-01

The construction industry is one of the biggest and most active sectors of the European Union (EU), consuming more raw materials and energy than any other economic activity. Furthermore, construction waste is the commonest waste produced in the EU. Current EU legislation sets out to implement construction and demolition waste (CDW) prevention and recycling measures. However it lacks tools to accelerate the development of a sector as bound by tradition as the building industry. The main objective of the present study was to determine indicators to estimate the amount of CDW generated on site both globally and by waste stream. CDW generation was estimated for six specific sectors: new residential construction, new non-residential construction, residential demolition, non-residential demolition, residential refurbishment, and non-residential refurbishment. The data needed to develop the indicators was collected through an exhaustive survey of previous international studies. The indicators determined suggest that the average composition of waste generated on site is mostly concrete and ceramic materials. Specifically for new residential and new non-residential construction the production of concrete waste in buildings with a reinforced concrete structure lies between 17.8 and 32.9 kg m(-2) and between 18.3 and 40.1 kg m(-2), respectively. For the residential and non-residential demolition sectors the production of this waste stream in buildings with a reinforced concrete structure varies from 492 to 840 kg m(-2) and from 401 to 768 kg/m(-2), respectively. For the residential and non-residential refurbishment sectors the production of concrete waste in buildings lies between 18.9 and 45.9 kg/m(-2) and between 18.9 and 191.2 kg/m(-2), respectively.

Evidence of natural occurrence of the banned antibiotic chloramphenicol in herbs and grass

PubMed Central

Berendsen, Bjorn; de Jong, Jacob; Nielen, Michel; Tserendorj, Enkhtuya; Sodnomdarjaa, Ruuragchas; Cannavan, Andrew; Elliott, Christopher

2010-01-01

Chloramphenicol (CAP), a broad-spectrum antibiotic, was detected in several herb and grass samples from different geographic origins. Due to its suspected carcinogenicity and linkages with the development of aplastic anemia in humans, CAP is banned for use in food-producing animals in the European Union (EU) and many other countries. However, products of animal origin originating from Asian countries entering the European market are still found noncompliant (containing CAP) on a regular basis, even when there is no history of chloramphenicol use in these countries. A possible explanation for the continued detection of these residues is the natural occurrence of CAP in plant material which is used as animal feed, with the consequent transfer of the substance to the animal tissues. Approximately 110 samples were analyzed using liquid chromatography coupled with mass spectrometric detection. In 26 samples, the presence of CAP was confirmed using the criteria for banned substances defined by the EU. Among other plant materials, samples of the Artemisia family retrieved from Mongolia and from Utah, USA, and a therapeutic herb mixture obtained from local stores in the Netherlands proved to contain CAP at levels ranging from 0.1 to 450 µg/kg. These findings may have a major impact in relation to international trade and safety to the consumer. The results of this study demonstrate that noncompliant findings in animal-derived food products may in part be due to the natural occurrence of chloramphenicol in plant material. This has implications for the application of current EU, USA, and other legislation and the interpretation of analytical results with respect to the consideration of CAP as a xenobiotic veterinary drug residue and the regulatory actions taken upon its detection in food. PMID:20431869

Certain aspects on medical devices software law regulation.

PubMed

Pashkov, Vitalii; Harkusha, Andrii

some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

From wastewater to fertilisers--Technical overview and critical review of European legislation governing phosphorus recycling.

PubMed

Hukari, Sirja; Hermann, Ludwig; Nättorp, Anders

2016-01-15

The present paper is based on an analysis of the EU legislation regulating phosphorus recovery and recycling from wastewater stream, in particular as fertiliser. To recover phosphorus, operators need to deal with market regulations, health and environment protection laws. Often, several permits and lengthy authorisation processes for both installation (e.g. environmental impact assessment) and the recovered phosphorus (e.g. End-of-Waste, REACH) are required. Exemptions to certain registration processes for recoverers are in place but rarely applied. National solutions are often needed. Emerging recovery and recycling sectors are affected by legislation in different ways: Wastewater treatment plants are obliged to remove phosphorus but may also recover it in low quantities for operational reasons. Permit processes allowing recovery and recycling operations next to water purification should thus be rationalised. In contrast, the fertiliser industry relies on legal quality requirements, ensuring their market reputation. For start-ups, raw-material sourcing and related legislation will be the key. Phosphorus recycling is governed by fragmented decision-making in regional administrations. Active regulatory support, such as recycling obligation or subsidies, is lacking. Legislation harmonisation, inclusion of recycled phosphorus in existing fertiliser regulations and support of new operators would speed up market penetration of novel technologies, reduce phosphorus losses and safeguard European quality standards.

Mail-order trade in medicines in Europe--a guide for legislators to protect consumers.

PubMed

Seeberg-Elverfeldt, Niels J

2009-12-01

This article discusses mail-order trade in medicines. It explains why this trade has developed and why there is a need for strict safety standards. The European Court of Justice obliged member states to allow such trade in non prescription medicines but did not specify any safety standards. The 2007 resolution of the Council of Europe lays these down precisely. An analysis of the legal situation in the 30 E.U. and E.E.A. states shows that they increasingly permit this trade. However, there are considerable deficits as regards the necessary safety standards. To protect consumers from illegal medicine sales via the internet, they should be able to easily identify legal products online. Legislators should act accordingly.

Moving the boundaries of international collaboration on clinical trials and QoL: experiences in oncology and legislation within the European Parliament.

PubMed

Bottomley, Andrew; Kirby, Tony; Bean, John; Walker, Julie

2013-02-01

The European Organisation for Research and Treatment of Cancer undertook another successful event with their third annual conference addressing quality of life matters in cancer clinical trials. More than 40 presentations were made over a 3-day period hosted at the European Parliament on 17-20 October 2012, in Brussels. The conference managed to get speakers and policy makers together to debate all the key issues in cancer clinical trials, design and reporting, including future policy and regulatory concerns. This meeting set the stage for future research and policy meetings to give greater visibility to quality of life as an outcome in clinical trials within the world of EU legislators.

Mitigation of CO2 emissions from the EU-15 building stock: beyond the EU Directive on the Energy Performance of Buildings.

PubMed

Petersdorff, Carsten; Boermans, Thomas; Harnisch, Jochen

2006-09-01

GOAL SCOPE AND BACKGROUND: The European Directive on Energy Performance of Buildings which came into force 16 December 2002 will be implemented in the legislation of Member States by 4 January 2006. In addition to the aim of improving the overall energy efficiency of new buildings, large existing buildings will become a target for improvement, as soon as they undergo significant renovation. The building sector is responsible for about 40% of Europe's total end energy consumption and hence this Directive is an important step for the European Union in order that it should reach the level of saving required by the Kyoto Agreement. In this the EU is committed to reduce CO2 emissions relative to the base year of 1990 by 8 per cent, by 2010. But what will be the impact of the new Directive, how large could be the impacts of extending the obligation for energy efficiency retrofitting towards smaller buildings? Can improvement of the insulation offset or reduce the growing energy consumption from the increasing installation of cooling installations? EURIMA, the European Insulation Manufacturers Association and EuroACE, the European Alliance of Companies for Energy Efficiency in Buildings, asked Ecofys to address these questions. The effect of the EPB Directive on the emissions associated with the heating energy consumption of the total EU 15 building stock has been examined in a model calculation, using the Built Environment Analysis Model (BEAM), which was developed by Ecofys to investigate energy saving measures in the building stock. The great complexity of the EU-15 building stock had to be simplified by examining five standard buildings with eight insulation standards, which are assigned to building age and renovation status. Furthermore, three climatic regions (cold, moderate, warm) were distinguished for the calculation of the heating energy demand. This gave a basic 210 building types for which the heating energy demand and CO2 emissions from heating were calculated according to the principles of the European Norm EN 832. The model calculations demonstrates that the main contributor to the total heating related CO2 emissions of 725 Mt/a from the EU building stock in 2002 is the residential sector (77%) while the remaining 23% originates from non-residential buildings. In the residential sector, single-family houses represent the largest group responsible for 60% of the total CO2 emissions equivalent to 435 Mt/a. THE TECHNICAL POTENTIAL: If all retrofit measures in the scope of the Directive were realised immediately for the complete residential and non-residential building stock the overall CO2 emission savings would add up to 82 Mt/a. An additional saving potential compared to the Directive of 69 Mt/a would be created if the scope of the Directive was extended to cover retrofit measures in multi-family dwellings (200-1000 m2) and non-residential buildings smaller than 1000 m2 used floor space. In addition including the large group of single-family dwellings would lead to a potential for additional CO2 emission reductions compared to the Directive of 316 Mt/a. TEMPORAL MOBILIZATION OF THE POTENTIAL: Calculations based on the building stock as it develops over time with average retrofit rates demonstrated that regulations introduced following the EPB Directive result in a CO2 emissions decrease of 34 Mt/a by the year 2010 compared to the business as usual scenario. Extending the scope of the EPB Directive to all residential buildings (including single and multi-family dwellings), the CO2 emission savings potential over the 'business as usual' scenario could be doubled to 69 Mt/a in the year 2010. This creates an additional saving potential compared to the Directive of 36 Mt/a. COOLING DEMAND: The analysis demonstrated that in warm climatic zones the cooling demand can be reduced drastically by a combination of lowering the internal heat loads and by improved insulation. With the reduction of the heat loads to a moderate level the cooling demand, e.g. of a terraced house located in Madrid, can be reduced by an additional 85% if the insulation level is improved appropriately. This study demonstrates that the European Directive on Energy Performance of Buildings will have a significant impact on the CO2 emissions of the European building stock. The main saving potential lies in insulation of the existing building stock. Beyond this, CO2 emissions could, however, be greatly reduced if the scope of the Directive were to be extended to include retrofit of smaller buildings. The reductions should be seen in relation to the remaining gap of 190 Mt CO2 eq. per annum between the current emission levels of EU-15 and the target under the Kyoto-Protocol for the year 2010. The energy and industrial sector will probably contribute only a fraction of this reduction via the newly established EU emissions trading scheme and connected projects under the flexible mechanism. In addition, the traffic sector is likely to continue its growth path leading to a widening of the gap. Thus, there is likely to be considerable pressure on the EU building sector to contribute to the EU climate targets beyond what will be achieved by means of the current EPB Directive. Legislators on the EU and national level are therefore advised to take accelerated actions to tap the very significant emission reduction potentials available in the EU building stock.

Eaux minérales naturelles et eaux de sources en Algérie

NASA Astrophysics Data System (ADS)

Hazzab, Abdelkrim

2011-01-01

An up-to-date inventory of natural mineral and spring waters in Algeria is here presented. First, the legislation regarding exploitation, production and marketing of the latter is compared to the EU and international ones. Then, a physicochemical characterization and classification of the water types are proposed as well as a tentative establishment of a database for natural mineral and spring waters in Algeria.

Precise plant breeding using new genome editing techniques: opportunities, safety and regulation in the EU.

PubMed

Hartung, Frank; Schiemann, Joachim

2014-06-01

Several new plant breeding techniques (NPBTs) have been developed during the last decade, and make it possible to precisely perform genome modifications in plants. The major problem, other than technical aspects, is the vagueness of regulation concerning these new techniques. Since the definition of eight NPBTs by a European expert group in 2007, there has been an ongoing debate on whether the resulting plants and their products are covered by GMO legislation. Obviously, cover by GMO legislation would severely hamper the use of NPBT, because genetically modified plants must pass a costly and time-consuming GMO approval procedure in the EU. In this review, we compare some of the NPBTs defined by the EU expert group with classical breeding techniques and conventional transgenic plants. The list of NPBTs may be shortened (or extended) during the international discussion process initiated by the Organization for Economic Co-operation and Development. From the scientific point of view, it may be argued that plants developed by NPBTs are often indistinguishable from classically bred plants and are not expected to possess higher risks for health and the environment. In light of the debate on the future regulation of NPBTs and the accumulated evidence on the biosafety of genetically modified plants that have been commercialized and risk-assessed worldwide, it may be suggested that plants modified by crop genetic improvement technologies, including genetic modification, NPBTs or other future techniques, should be evaluated according to the new trait and the resulting end product rather than the technique used to create the new plant variety. © 2013 The Authors The Plant Journal © 2013 John Wiley & Sons Ltd.

Analysis of environmental impact assessment (EIA) system in Turkey.

PubMed

Coşkun, Aynur Aydın; Turker, Ozhan

2011-04-01

The Environmental Impact Assessment (EIA) System, which embodies the "prevention principle" of the environmental law, is an important tool for environmental protection. This tool has a private importance for Turkey since it is a developing country, and it entered the Turkish law in 1983 with the Environmental Law. Besides, the EIA Regulation, which shows the application principles, became effective in 1993. Because Turkey is a candidate for European Union (EU), the EIA Regulation has been changed due to the EU compliance procedure, and its latest version became valid in 2008. This study aims to emphasize The EIA system in Turkey to supervise the efficiency of this procedure and point the success level. In the introduction part, general EIA concept, its importance, and some notations are mentioned. Following that, the legislation, which builds the EIA system, has been analyzed starting from the 1982 Turkish Constitution. Then, the legislation rules are explained due to the basic steps of the EIA procedure. In order to shed light upon the application, the EIA final decisions given until today, the results, and their distributions to the industries are assessed. In the final part of the study, a SWOT analysis is made to mention the weaknesses, strengths, opportunities, and threats of the EIA system in Turkey.

Pharmacovigilance in pharmaceutical companies: An overview

PubMed Central

Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

2013-01-01

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs). PMID:24347978

Pharmacovigilance in pharmaceutical companies: An overview.

PubMed

Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

2013-12-01

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

Ethical, legal, and social aspects of farm animal cloning in the 6th Framework Programme for Research.

PubMed

Claxton, John; Sachez, Elena; Matthiessen-Guyader, Line

2004-01-01

Cloned livestock have potential importance in the provision of improved medicine as well as in the development of livestock production. The public is, however, increasingly concerned about the social and ethical consequences of these advances in knowledge and techniques. There is unevenness throughout Europe in different Member States' attitudes to research into livestock cloning. Although there is EU legislation controlling the use of animals for research purposes, there is no legislation specifically governing cloning in livestock production. The main EU reference is the 9th Opinion of the European Group on Ethics, which states "Cloning of farm animals may prove to be of medical and agricultural as well as economic benefit. It is acceptable only when the aims and methods are ethically justified and when carried out under ethical conditions." The ethical justification includes the avoidance of suffering, the use of the 3Rs principle and a lack of better alternatives. The Commission addresses these issues in the 6th Framework Programme by promoting the integration of ethical, legal and social aspects in all proposals where they are relevant, by fostering ethical awareness and foresight in the proposals, by encouraging public dialogue, and by supporting specific actions to promote the debate. Research must respect fundamental ethical principles, including animal welfare requirements.

The EU-regulation on medicinal products for paediatric use: impacts on child and adolescent psychiatry and clinical research with minors.

PubMed

Kölch, Michael; Schnoor, Kathlen; Fegert, Jörg M

2007-06-01

At present the EU-regulation on medicinal products for paediatric use is in the final legislation phase. The Regulation will bring essential changes to the policy of research with minors, to funding and to regulations of drug development in Europe. The article analyses contents of the regulation and possible effects on research with and treatment of mentally ill minors. The regulation seems to be a chance to improve pharmacological treatment for children and bring similar research conditions to Europe as they already exist in the US. Some terms of the regulation must be considered as critical due to vague definitions and ambiguously defined policies in some articles. The designated expert committee will be a powerful institution, but it remains to be seen whether this committee will act in the intended way. It is an existing and real danger that European child and adolescent psychiatry will be neglected by the new regulation, if there is no participation of scientists of this discipline in committees. The regulation makes it necessary for child and adolescent psychiatry to strengthen research in clinical trials and developmental psychopharmacology to get benefits from new legislation and improve health care for mentally ill minors.

Review of 11 national policies for rare diseases in the context of key patient needs.

PubMed

Dharssi, Safiyya; Wong-Rieger, Durhane; Harold, Matthew; Terry, Sharon

2017-03-31

Rare diseases collectively exert a global public health burden in the severity of their manifestations and the total number of people they afflict. For many patients, considerable barriers exist in terms of access to appropriate care, delayed diagnosis and limited or non-existing treatment options. Motivated by these challenges, the rare disease patient community has played a critical role, elevating the patient voice and mobilizing legislation to support the development of programs that address the needs of patients with rare diseases.The US Orphan Drug Act of 1983 served as a key milestone in this journey, providing a roadmap for other countries to introduce and implement similar orphan drug legislation; more recently, the European Union (EU) has gone further to encourage the widespread adoption and implementation of rare disease plans or strategies designed to more adequately address the comprehensive needs of patients with rare diseases. Despite these legislative efforts and the growing contributions of patient advocacy groups in moving forward implementation and adoption of rare disease programs, gaps still exist across the policy landscape for several countries. To gain deeper insights into the challenges and opportunities to address key needs of rare disease patients, it is critical to define the current status of rare disease legislation and policy across a geographically and economically diverse selection of countries. We analyzed the rare disease policy landscape across 11 countries: Germany, France, the United Kingdom, Canada, Bulgaria, Turkey, Argentina, Mexico, Brazil, China, and Taiwan. The status and implementation of policy was evaluated for each country in the context of key patient needs across 5 dimensions: improving coordination of care, diagnostic resources, access to treatments, patient awareness and support, and promoting innovative research. Our findings highlight the continuing role of the patient community in driving the establishment and adoption of legislation and programs to improve rare disease care. Further, we found that while national rare disease plans provide important guidance for improving care, implementation of plans is uneven across countries. More research is needed to demonstrate the effect of specific elements of rare disease plans on patient outcomes.

Air quality management: evolution of policy and practice in the UK as exemplified by the experience of English local government

NASA Astrophysics Data System (ADS)

Beattie, C. I.; Longhurst, J. W. S.; Woodfield, N. K.

The air quality management (AQM) framework in the UK is designed to be an effects-based solution to air pollutants currently affecting human health. The AQM process has been legislated through The Environment Act 1995, which required the National Air Quality Strategy (NAQS) to be published. AQM practice and capability within local authorities has flourished since the publication of the NAQS in March 1997. This paper outlines the policy framework within which the UK operates, both at a domestic and European level, and reviews the air quality management process relating to current UK policy and EU policy. Data from questionnaire surveys are used to indicate the involvement of various sectors of local government in the air quality management process. These data indicate an increasing use of monitoring, and use of air dispersion modelling by English local authorities. Data relating to the management of air quality, for example, the existence and work of air quality groups, dissemination of information to the public and policy measures in place on a local scale to improve air quality, have also been reported. The UK NAQS has been reviewed in 1999 to reflect developments in European legislation, technological and scientific advances, improved air pollution modelling techniques and an increasingly better understanding of the socio-economic issues involved. The AQM process, as implemented by UK local authorities, provides an effective model for other European member states with regards to the implementation of the Air Quality Framework Directive. The future direction of air quality policy in the UK is also discussed.

European and German food legislation facing uncommon foodstuffs.

PubMed

Grabowski, Nils Th; Klein, Günter; López, Antonio Martínez

2013-01-01

In Europe, uncommon foodstuff (UFS, i.e., traditional foods from specific European regions and uncommon ethnic foods from non-EU countries) have been contributing to a diversification of the food supply. E-commerce and specialized retail shops are the main sources for UFS. This article discusses the legal bases for UFS introduction and evaluation. By means of 35 representative UFS, this article analyses the possibilities of trade and veterinary inspection of these products in Germany, comparing European Union and national food legislation with the many idiosyncrasies the UFS presents. Conservatory legislation bans the trade with endangered species (primates, cetaceans, songbirds), but for many other species, this is a complex matter that may ban only subpopulations from trade. Although introduction of legal UFS is regulated (yet complicated), the lack of appropriate definitions, intra-European trade harmonization, and of sufficient scientific knowledge hampers a satisfactory evaluation of many UFSs, for example, reptile meat or terrestrial insects. In these cases, official inspection would only be very basic.

PRICING, REIMBURSEMENT, AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICINAL PRODUCTS IN BULGARIA.

PubMed

Benisheva-Dimitrova, Tatyana; Sidjimova, Dobriana; Cherneva, Daniela; Kralimarkov, Nikolay

2017-01-01

The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

Off-label prescription of genetically modified organism medicines in europe: emerging conflicts of interest?

PubMed

Schagen, Frederik H E; Hoeben, Rob C; Hospers, Geke A P

2014-10-01

Recently, the first human medicine containing a genetically modified organism (GMO medicine) was authorized for use in the European market. Just as any medicinal product, the market authorization for a GMO medicine contains a precise description of the therapeutic use for which the medicinal product is intended. Within this use, the application of the GMO medicine is permitted, without the need for the institution to obtain a specific permit. In practice, however, medicinal products are also frequently prescribed for treatment outside the registered therapeutic use, a practice that is referred to as "off-label use." While off-label use of conventional medicines is permitted and has been very useful, the off-label use of GMO medicines is not covered in the European Union (EU) legislation or guidelines and falls under each member state's national environmental legislation. This implies that in the Netherlands and most other EU member states, an environmental permit will be required for any institution that uses the GMO medicine outside the registered application(s). In the Netherlands, this permit is identical to the permits required for the execution of clinical trials involving nonregistered GMOs. The application procedure for such permit is time-consuming. This process can therefore limit the therapeutic options for medical professionals. As a consequence, desired treatment regimens could be withheld for certain patient (groups). To make future off-label use of GMO medicines permissible in a way that is acceptable for all stakeholders, regulators should adopt a proactive attitude and formulate transparent legislative procedures for this. Only then the field can maintain the public acceptance of GMO medicines, while maintaining the freedom to operate of medical professionals.

Twentieth anniversary of the European Union health mandate: taking stock of perceived achievements, failures and missed opportunities - a qualitative study.

PubMed

Rosenkötter, Nicole; Clemens, Timo; Sørensen, Kristine; Brand, Helmut

2013-11-14

The European Union (EU) health mandate was initially defined in the Maastricht Treaty in 1992. The twentieth anniversary of the Treaty offers a unique opportunity to take stock of EU health actions by giving an overview of influential public health related EU-level policy outputs and a summary of policy outputs or actions perceived as an achievement, a failure or a missed opportunity. Semi-structured expert interviews (N = 20) were conducted focusing on EU-level actions that were relevant for health. Respondents were asked to name EU policies or actions that they perceived as an achievement, a failure or a missed opportunity. A directed content analysis approach was used to identify expert perceptions on achievements, failures and missed opportunities in the interviews. Additionally, a nominal group technique was applied to identify influential and public health relevant EU-level policy outputs. The ranking of influential policy outputs resulted in top positions of adjudications and legislations, agencies, European Commission (EC) programmes and strategies, official networks, cooperative structures and exchange efforts, the work on health determinants and uptake of scientific knowledge. The assessment of EU health policies as being an achievement, a failure or a missed opportunity was often characterized by diverging respondent views. Recurring topics that emerged were the Directorate General for Health and Consumers (DG SANCO), EU agencies, life style factors, internal market provisions as well as the EU Directive on patients' rights in cross-border healthcare. Among these recurring topics, expert perceptions on the establishment of DG SANCO, EU public health agencies, and successes in tobacco control were dominated by aspects of achievements. The implementation status of the Health in All Policy approach was perceived as a missed opportunity. When comparing the emerging themes from the interviews conducted with the responsibilities defined in the EU health mandate, one can identify that these responsibilities were only partly fulfilled or acknowledged by the respondents. In general, the EU is a recognized public health player in Europe which over the past two decades, has begun to develop competencies in supporting, coordinating and supplementing member state health actions. However, the assurance of health protection in other European policies seems to require further development.

Twentieth anniversary of the European Union health mandate: taking stock of perceived achievements, failures and missed opportunities – a qualitative study

PubMed Central

2013-01-01

Background The European Union (EU) health mandate was initially defined in the Maastricht Treaty in 1992. The twentieth anniversary of the Treaty offers a unique opportunity to take stock of EU health actions by giving an overview of influential public health related EU-level policy outputs and a summary of policy outputs or actions perceived as an achievement, a failure or a missed opportunity. Methods Semi-structured expert interviews (N = 20) were conducted focusing on EU-level actions that were relevant for health. Respondents were asked to name EU policies or actions that they perceived as an achievement, a failure or a missed opportunity. A directed content analysis approach was used to identify expert perceptions on achievements, failures and missed opportunities in the interviews. Additionally, a nominal group technique was applied to identify influential and public health relevant EU-level policy outputs. Results The ranking of influential policy outputs resulted in top positions of adjudications and legislations, agencies, European Commission (EC) programmes and strategies, official networks, cooperative structures and exchange efforts, the work on health determinants and uptake of scientific knowledge. The assessment of EU health policies as being an achievement, a failure or a missed opportunity was often characterized by diverging respondent views. Recurring topics that emerged were the Directorate General for Health and Consumers (DG SANCO), EU agencies, life style factors, internal market provisions as well as the EU Directive on patients’ rights in cross-border healthcare. Among these recurring topics, expert perceptions on the establishment of DG SANCO, EU public health agencies, and successes in tobacco control were dominated by aspects of achievements. The implementation status of the Health in All Policy approach was perceived as a missed opportunity. Conclusions When comparing the emerging themes from the interviews conducted with the responsibilities defined in the EU health mandate, one can identify that these responsibilities were only partly fulfilled or acknowledged by the respondents. In general, the EU is a recognized public health player in Europe which over the past two decades, has begun to develop competencies in supporting, coordinating and supplementing member state health actions. However, the assurance of health protection in other European policies seems to require further development. PMID:24225055

Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union.

PubMed

Inácio, P; Cavaco, A; Allan, E; Airaksinen, M

2018-02-01

In the European Union (EU), legislation allows patients to directly report adverse drug reactions (ADRs) to competent authorities. Five years after its implementation, patient reporting is not equal in all countries. This study aimed to explore key stakeholders' perceptions of patient reporting in four EU countries. Qualitative study design. Twelve representatives from national pharmacovigilance centres and/or authorities as well as national pharmaceutical industry bodies in four EU countries participated in the study. Supranational organizations were also included. Data collection was via face-semi-structured interviews. Inductive content analysis was performed thereafter, applying principles of risk management as a theoretical framework. Four themes (attitudes and beliefs, system maturation factors, regulatory improvements, and cultural shifts) emerged, conceptually interconnected. Participants from countries introducing patient reporting recently expressed a negative attitude. Participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. The findings identified perceived barriers and facilitators of patient reporting. The involvement of patients, use of information, and dissemination of patient reporting are far from optimal. A better integration of the work by EU regulatory authorities is recommended. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Relevance of the EU Structural Funds’ Allocation to the Needs of Combating Air Pollution in Poland. Analysis of the Operational Programmes of Regions Threatened With Critical Air Pollution from Distributed Energy Sources

NASA Astrophysics Data System (ADS)

Włodarski, Marcin; Martyniuk-Pęczek, Justyna

2017-10-01

Recent years, the European Environmental Agency, has been reporting air quality parameters in Poland, as the poorest among all the EU countries. Despite of adoption of the EU legislation on energy efficiency and energy performance of buildings, existing legal solutions occur insufficient in reducing air pollution in Polish regions. Lack of an effective schemes supporting complex thermal renovation of buildings, exchange of inefficient boilers, developing district heating based on clean and renewable fuels results in severe health problems and 40 000 of premature deaths related to air pollution. Availability of the EU structural funds may become a tremendous opportunity, especially for the residential sector, to conduct a massive scale modernization. Nevertheless, lack of a coordinated action involving all levels of governance may put the opportunity at risk. The article aims to answer the question on the readiness of the regional governments to effectively implement energy efficiency measures mitigating the problem of air pollution. Second objective is to analyse whether the Regional Operational Programmes allocating the ERDF funds to support specific development needs of the regions, have been constructed in a way that properly addresses the problems related to energy performance of residential buildings.

The Effect of Steps to Promote Higher Levels of Farm Animal Welfare across the EU. Societal versus Animal Scientists' Perceptions of Animal Welfare.

PubMed

Averós, Xavier; Aparicio, Miguel A; Ferrari, Paolo; Guy, Jonathan H; Hubbard, Carmen; Schmid, Otto; Ilieski, Vlatko; Spoolder, Hans A M

2013-08-14

Information about animal welfare standards and initiatives from eight European countries was collected, grouped, and compared to EU welfare standards to detect those aspects beyond minimum welfare levels demanded by EU welfare legislation. Literature was reviewed to determine the scientific relevance of standards and initiatives, and those aspects going beyond minimum EU standards. Standards and initiatives were assessed to determine their strengths and weaknesses regarding animal welfare. Attitudes of stakeholders in the improvement of animal welfare were determined through a Policy Delphi exercise. Social perception of animal welfare, economic implications of upraising welfare levels, and differences between countries were considered. Literature review revealed that on-farm space allowance, climate control, and environmental enrichment are relevant for all animal categories. Experts' assessment revealed that on-farm prevention of thermal stress, air quality, and races and passageways' design were not sufficiently included. Stakeholders considered that housing conditions are particularly relevant regarding animal welfare, and that animal-based and farm-level indicators are fundamental to monitor the progress of animal welfare. The most notable differences between what society offers and what farm animals are likely to need are related to transportation and space availability, with economic constraints being the most plausible explanation.

Legal frameworks and key concepts regulating diversion and treatment of mentally disordered offenders in European Union member states.

PubMed

Dressing, Harald; Salize, Hans Joachim; Gordon, Harvey

2007-10-01

There is only limited research on the various legal regulations governing assessment, placement and treatment of mentally ill offenders in European Union member states (EU-member states). To provide a structured description and cross-boundary comparison of legal frameworks regulating diversion and treatment of mentally disordered offenders in EU-member states before the extension in May 2004. A special focus is on the concept of criminal responsibility. Information on legislation and practice concerning the assessment, placement and treatment of mentally ill offenders was gathered by means of a detailed, structured questionnaire which was filled in by national experts. The legal regulations relevant for forensic psychiatry in EU-member states are outlined. Definitions of mental disorders given within these acts are introduced and compared with ICD-10 diagnoses. Finally the application of the concept of criminal responsibility by the law and in routine practice is presented. Legal frameworks for the processing and placement of mentally disordered offenders varied markedly across EU-member states. Since May 2004 the European Union has expanded to 25 member states and in January 2007 it will reach 27. With increasing mobility across Europe, the need for increasing trans-national co-operation is becoming apparent in which great variation in legal tradition pertains.

A new process for NOx reduction in combustion systems for the generation of energy from waste.

PubMed

Gohlke, Oliver; Weber, Toralf; Seguin, Philippe; Laborel, Yann

2010-07-01

In the EU, emissions from energy from waste plants are largely reduced by applying the Waste Incineration Directive with its limit of 200 mg/m3(s) for NO(x) emissions. The need for further improvement is reflected by new German legislation effective as of 27 January 2009, requiring 100 mg/m3(s). Other countries are expected to follow this example due to the national emission ceilings of the Gothenburg protocol and the concluding EU directive 2001/81/EC. On the other hand, an increase in energy efficiency will be encouraged by the EU Waste Framework Directive. This is why there is a need for new technologies that make it possible to reconcile both requirements: reduced emissions and increased energy efficiency. A new process combining the internal recirculation of flue gas with ammonia or urea injection in order to achieve less then 80 mg/m3(s) of NO(x) is described. Important additional features of the process are an R1 efficiency above the required 0.65 of the EU Waste Framework Directive even with standard steam parameters of 40 bar/380 degrees C as well as low ammonia slip in the flue gas at the boiler outlet of below 10 mg/m3(s). Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Implementing the US air quality standard for PM2.5 worldwide can prevent millions of premature deaths per year.

PubMed

Giannadaki, Despina; Lelieveld, Jos; Pozzer, Andrea

2016-08-23

Air pollution by fine aerosol particles is among the leading causes of poor health and premature mortality worldwide. The growing awareness of this issue has led several countries to implement air pollution legislation. However, populations in large parts of the world are still exposed to high levels of ambient particulate pollution. The main aim of this work is to evaluate the potential impact of implementing current air quality standards for fine particulate matter (PM2.5) in the European Union (EU), United States (US) and other countries where PM2.5 levels are high. We use a high-resolution global atmospheric chemistry model combined with epidemiological concentration response functions to investigate premature mortality attributable to PM2.5 in adults ≥30 years and children <5 years. We perform sensitivity studies to estimate the reductions in mortality that could be achieved if the PM2.5 air quality standards of the EU and US and other national standards would be implemented worldwide. We estimate the global premature mortality by PM2.5 at 3.15 million/year in 2010. China is the leading country with about 1.33 million, followed by India with 575 thousand and Pakistan with 105 thousand per year. For the 28 EU member states we estimate 173 thousand and for the United States 52 thousand premature deaths in 2010. Based on sensitivity analysis, applying worldwide the EU annual mean standard of 25 μg/m(3) for PM2.5 could reduce global premature mortality due to PM2.5 exposure by 17 %; while within the EU the effect is negligible. With the 2012 revised US standard of 12 μg/m(3) premature mortality by PM2.5 could drop by 46 % worldwide; 4 % in the US and 20 % in the EU, 69 % in China, 49 % in India and 36 % in Pakistan. These estimates take into consideration that about 22 % of the global PM2.5 related mortality cannot be avoided due to the contribution of natural PM2.5 sources, mainly airborne desert dust and PM2.5 from wild fires. Our results reflect the need to adopt stricter limits for annual mean PM2.5 levels globally, like the US standard of 12 μg/m(3) or an even lower limit to substantially reduce premature mortality in most of the world.

Environmental Impact Assessment in the marine environment: A comparison of legal frameworks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guerra, Flávia, E-mail: f.c.diasguerra@vu.nl; Liga para a Protecção da Natureza, 1500-124 Lisboa; Grilo, Catarina

Environmental Impact Assessment (EIA) is a well-established practice in most developed countries, even though its application to projects in the marine environment is at a much earlier stage of development. We use the Portuguese example to address marine EIA legislation since its exclusive economic zone (EEZ) is currently the third largest in the European Union and its EIA legislation does not require various offshore activities with potentially negative environmental impacts to undergo EIA before being licensed. This paper aims to determine whether three types of projects implemented within Portuguese maritime zones – artificial reefs using sunken ships, hydrocarbon prospecting andmore » wave-energy generation – would benefit from application of an appropriately designed EIA. We have conducted a structured review of EIA legal provisions from seven other countries, and considered whether a full EIA was required for each project type. Consequently, 12 Environmental Impact Statements (EIS) have been compared to identify patterns of (dis)similarity across countries and project types. Additionally, we identified key descriptors and predicted impacts for each project type referred to in their EIS. The main conclusion is that ultimately all three projects would benefit from mandatory EIA in Portugal. This paper is relevant for countries with large maritime areas and underdeveloped marine EIA legislation, helping improve international policy-making relating to these three types of marine projects. - Highlights: • EIA is not mandatory for some project types developed in Portuguese maritime zones. • Artificial reefs, oil&gas prospecting and wave-energy licensing differ in 8 countries. • EIA should be mandatory in Portugal for artificial reefs and oil&gas prospecting. • However, an AEInc approach is enough for wave-energy projects in Portugal. • Findings could be extended to other EU countries with extensive maritime zones.« less

Determining the status of non-transferred embryos in Ireland: a conspectus of case law and implications for clinical IVF practice

PubMed Central

Sills, Eric Scott; Murphy, Sarah Ellen

2009-01-01

The development of in vitro fertilisation (IVF) as a treatment for human infertilty was among the most controversial medical achievements of the modern era. In Ireland, the fate and status of supranumary (non-transferred) embryos derived from IVF brings challenges both for clinical practice and public health policy because there is no judicial or legislative framework in place to address the medical, scientific, or ethical uncertainties. Complex legal issues exist regarding informed consent and ownership of embryos, particularly the use of non-transferred embryos if a couple separates or divorces. But since case law is only beginning to emerge from outside Ireland and because legislation on IVF and human embryo status is entirely absent here, this matter is poised to raise contractual, constitutional and property law issues at the highest level. Our analysis examines this medico-legal challenge in an Irish context, and summarises key decisions on this issue rendered from other jurisdictions. The contractual issues raised by the Roche case regarding informed consent and the implications the initial judgment may have for future disputes over embryos are also discussed. Our research also considers a putative Constitutional 'right to procreate' and the implications EU law may have for an Irish case concerning the fate of frozen embryos. Since current Medical Council guidelines are insufficient to ensure appropriate regulation of the advanced reproductive technologies in Ireland, the report of the Commission on Assisted Human Reproduction is most likely to influence embryo custody disputes. Public policy requires the establishment and implementation of a more comprehensive legislative framework within which assisted reproductive medical services are offered. PMID:19589140

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists.

PubMed

Merks, Piotr; Swieczkowski, Damian; Byliniak, Michal; Drozd, Mariola; Krupa, Katarzyna; Jaguszewski, Milosz; Brindley, David A; Naughton, Bernard D

2018-01-01

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD.

Study on Laws, Regulations and Standards on Energy Efficiency, Energy Conserving and Emission Reduction of Industrial Boilers in EU

NASA Astrophysics Data System (ADS)

Liu, Ren; Zhao, Yuejin; Chen, Haihong; Liang, Xiuying; Yang, Ming

2017-12-01

Industrial boilers are widely applied in such fields as factory power, building heating, and people’s lives; China is the world’s largest producer and user of industrial boilers, with very high annual energy consumption; clear requirements have been put forward by China on the energy efficiency since the “11th Five-year Plan” with the hope to save energy and reduce emission by means of energy efficiency standards and regulations on the supervision and control of various special equipment. So far, the energy efficiency of industrial boilers in China has been improved significantly but there is still a gap with the EU states. This paper analyzes the policies of energy efficiency, implementation models and methods of supervision and implementation at the EU level from laws, regulations, directives as well as standards; the paper also puts forward suggestions of energy conserving and emission reduction on the improvement of energy conserving capacity of industrial boilers in China through studying the legislations and measures of the developed countries in energy conserving of boilers.

Comparison of the portion size and frequency of consumption of 156 foods across seven European countries: insights from the Food4ME study.

PubMed

Kirwan, L; Walsh, M C; Brennan, L; Gibney, E R; Drevon, C A; Daniel, H; Lovegrove, J A; Manios, Y; Martínez, J A; Saris, W H M; Traczyk, I; Mathers, J C; Gibney, M

2016-05-01

There are no standardised serving/portion sizes defined for foods consumed in the European Union (EU). Typical serving sizes can deviate significantly from the 100 g/100 ml labelling specification required by the EU legislation. Where the nutritional value of a portion is specified, the portion size is determined by the manufacturers. Our objective was to investigate the potential for standardising portion sizes for specific foods, thereby ensuring complementarity across countries. We compared portion size for 156 food items measured using a food frequency questionnaire across the seven countries participating in the Food4me study. The probability of consuming a food and the frequency of consumption differed across countries for 93% and 58% of the foods, respectively. However, the individual country mean portion size differed from the average across countries in only 16% of comparisons. Thus, although dietary choices vary markedly across countries, there is much less variation in portion sizes. Our results highlight the potential for standardisation of portion sizes on nutrition labels in the EU.

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists

PubMed Central

Merks, Piotr; Swieczkowski, Damian; Byliniak, Michal; Drozd, Mariola; Krupa, Katarzyna; Jaguszewski, Milosz; Brindley, David A; Naughton, Bernard D

2018-01-01

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD. PMID:29445453

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

PubMed

Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

2016-10-01

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

Monitoring the prevalence of genetically modified maize in commercial animal feeds and food products in Turkey.

PubMed

Turkec, Aydin; Lucas, Stuart J; Karlık, Elif

2016-07-01

EU legislation strictly controls use of genetically modified (GM) crops in food and feed products, and requires them to be labelled if the total GM content is greater than 9 g kg(-1) (for approved GM crops). We screened maize-containing food and feed products from Turkey to assess the prevalence of GM material. With this aim, 83 food and feed products - none labelled as containing GM material - were screened using multiplex real-time polymerase chain reaction (PCR) for four common GM elements (35S/NOS/bar/FMV). Of these, 18.2% of feeds and 6% of food samples tested positive for one or more of these elements, and were subjected to event-specific PCR to identify which GM organisms they contained. Most samples were negative for the approved GM events tested, suggesting that they may contain adventitious GM contaminants. One sample was shown to contain an unapproved GM event (MON810, along with GA21) at a concentration well above the statutory labelling requirement. Current legislation has restricted the penetration of GM maize into the Turkish food industry but not eliminated it, and the proliferation of different GM events is making monitoring increasingly complex. Our results indicate that labelling requirements are not being followed in some cases. © 2015 Society of Chemical Industry. © 2015 Society of Chemical Industry.

EU Directive 2004/40: field measurements of a 1.5 T clinical MR scanner.

PubMed

Riches, S F; Collins, D J; Scuffham, J W; Leach, M O

2007-06-01

The European Union (EU) Physical Agents (EMF) Directive [1] must be incorporated into UK law in 2008. The directive, which applies to employees working in MRI, sets legal exposure limits for two of the three types of EMF exposure employed in MRI; time-varying gradient fields and radiofrequency (RF) fields. Limits on the static field are currently not included but may be added at a later date. Conservative action values have been set for all three types of exposure including the static field. The absolute exposure limits will exclude staff from the scanner bore and adjacent areas during scanning, impacting on many clinical activities such as anaesthetic monitoring during sedated scans, paediatric scanning and interventional MRI. When the legislation comes into force, NHS Trusts, scanner companies and academic institutions will be required to show compliance with the law. We present results of initial measurements performed on a 1.5 T clinical MRI scanner. For the static field, the proposed action value is exceeded at 40 cm from the scanner bore and would be exceeded when positioning a patient for scanning. For the RF field, the action values were only exceeded within the bore at distances of 40 cm from the scanner ends during a very RF intensive sequence; MRI employees are unlikely to be in the bore during an acquisition. For the time-varying gradient fields the action values were exceeded 52 cm out from the mouth of the bore during two clinical sequences, and estimated current densities show the exposure limit to be exceeded at 40 cm for frequencies above 333 Hz. Limiting employees to distances greater than these from the scanner during acquisition will have a severe impact on the future use and development of MRI.

Determination of ultratrace levels of tributyltin in waters by isotope dilution and gas chromatography coupled to tandem mass spectrometry.

PubMed

Rodríguez-Cea, Andrés; Rodríguez-González, Pablo; Font Cardona, Nuria; Aranda Mares, José Luís; Ballester Nebot, Salomé; García Alonso, J Ignacio

2015-12-18

The current EU legislation lays down the Environmental Quality Standards (EQS) of 45 priority substances in surface water bodies. In particular, the concentration of tributyltin (TBT) must not exceed 0.2ngL(-1) and analytical methodologies with a Limit of Quantification (LOQ) equal or below 0.06ngL(-1) are urged to be developed. This work presents a procedure for the determination of ultratrace levels of TBT in water samples by Isotope Dilution and GC-MS/MS operating in Selected Reaction Monitoring (SRM) mode which meets current EU requirements. The method requires the monitorization of five consecutive transitions (287>175 to 291>179) for the sensitive and selective detection of TBT. The measured isotopic distribution of TBT fragment ions was in agreement with the theoretical values computed by a polynomial expansion algorithm. The combined use of Tandem Mass Spectrometry, a sample volume of 250mL, the preconcentration of 1mL of organic phase to 30μL and an injection volume of 25μL by Programmed Temperature Vaporization provided a LOQ of 0.0426ngL(-1) for TBT (calculated as ten times the standard deviation of nine independent blanks). The recovery for TBT calculated in Milli-Q water at the EQS level was 106.3±4%. A similar procedure was also developed for the quantification of dibutyltin (DBT) and monobutyltin (MBT) in water samples showing satisfactory results. The method was finally implemented in a routine testing laboratory to demonstrate its applicability to real samples obtaining quantitative recoveries for TBT at the EQS level in mineral water, river water and seawater. Copyright © 2015 Elsevier B.V. All rights reserved.

Estimation of end of life mobile phones generation: The case study of the Czech Republic

DOE Office of Scientific and Technical Information (OSTI.GOV)

Polak, Milos, E-mail: mpolak@remasystem.cz; Drapalova, Lenka

Highlights: Black-Right-Pointing-Pointer In this paper, we define lifespan of mobile phones and estimate their average total lifespan. Black-Right-Pointing-Pointer The estimation of lifespan distribution is based on large sample of EoL mobile phones. Black-Right-Pointing-Pointer Total lifespan of Czech mobile phones is surprisingly long, exactly 7.99 years. Black-Right-Pointing-Pointer In the years 2010-20, about 26.3 million pieces of EoL mobile phones will be generated in the Czech Republic. - Abstract: The volume of waste electrical and electronic equipment (WEEE) has been rapidly growing in recent years. In the European Union (EU), legislation promoting the collection and recycling of WEEE has been in forcemore » since the year 2003. Yet, both current and recently suggested collection targets for WEEE are completely ineffective when it comes to collection and recycling of small WEEE (s-WEEE), with mobile phones as a typical example. Mobile phones are the most sold EEE and at the same time one of appliances with the lowest collection rate. To improve this situation, it is necessary to assess the amount of generated end of life (EoL) mobile phones as precisely as possible. This paper presents a method of assessment of EoL mobile phones generation based on delay model. Within the scope of this paper, the method has been applied on the Czech Republic data. However, this method can be applied also to other EoL appliances in or outside the Czech Republic. Our results show that the average total lifespan of Czech mobile phones is surprisingly long, exactly 7.99 years. We impute long lifespan particularly to a storage time of EoL mobile phones at households, estimated to be 4.35 years. In the years 1990-2000, only 45 thousands of EoL mobile phones were generated in the Czech Republic, while in the years 2000-2010 the number grew to 6.5 million pieces and it is estimated that in the years 2010-2020 about 26.3 million pieces will be generated. Current European legislation sets targets on collection and recycling of WEEE in general, but no specific collection target for EoL mobile phone exists. In the year 2010 only about 3-6% of Czech EoL mobile phones were collected for recovery and recycling. If we make similar estimation using an estimated average EU value, then within the next 10 years about 1.3 billion of EoL mobile phones would be available for recycling in the EU. This amount contains about 31 tonnes of gold and 325 tonnes of silver. Since Europe is dependent on import of many raw materials, efficient recycling of EoL products could help reduce this dependence. To set a working system of collection, it will be necessary to set new and realistic collection targets.« less

Assessments of direct human exposure: the approach of EU risk assessments compared to scenario-based risk assessment.

PubMed

Wormuth, Matthias; Demou, Evangelia; Scheringer, Martin; Hungerbühler, Konrad

2007-08-01

The awareness of potential risks emerging from the use of chemicals in all parts of daily life has increased the need for risk assessments that are able to cover a high number of exposure situations and thereby ensure the safety of workers and consumers. In the European Union (EU), the practice of risk assessments for chemicals is laid down in a Technical Guidance Document; it is designed to consider environmental and human occupational and residential exposure. Almost 70 EU risk assessment reports (RARs) have been finalized for high-production-volume chemicals during the last decade. In the present study, we analyze the assessment of occupational and consumer exposure to trichloroethylene and phthalates presented in six EU RARs. Exposure scenarios in these six RARs were compared to scenarios used in applications of the scenario-based risk assessment approach to the same set of chemicals. We find that scenarios used in the selected EU RARs to represent typical exposure situations in occupational or private use of chemicals and products do not necessarily represent worst-case conditions. This can be due to the use of outdated information on technical equipment and conditions in workplaces or omission of pathways that can cause consumer exposure. Considering the need for exposure and risk assessments under the new chemicals legislation of the EU, we suggest that a transparent process of collecting data on exposure situations and of generating representative exposure scenarios is implemented to improve the accuracy of risk assessments. Also, the data sets used to assess human exposure should be harmonized, summarized in a transparent fashion, and made accessible for all risk assessors and the public.

EU Accession and Civil Aviation Regimes: Malta and Cyprus as a Case Study

NASA Technical Reports Server (NTRS)

Papatheodorou, Andreas; Busuttil, Louis

2003-01-01

Aviation deregulation is usually a challenging and demanding task and accession to the European Union requires that all candidate states should harmonize their legislation in the context of the European Common Aviation Area. Malta and Cyprus, the small Mediterranean island-states to join the EU in 2004, will have to abandon any protectionist policies in favour of their flag-carriers and let them survive in a liberal framework. The paper discusses the implications of this regime change for civil aviation in Malta and Cyprus and in addition to the airline industry, it examines the impacts on the complementary tourism sector. Unless carrying capacity limits are understood, the islands may become victims of successful airline liberalisation. The paper concludes by stressing the need for sustainable development and active policy making. Keywords: carrying capacity, Cyprus, air transport deregulation, Malta, tourism

Implementation of the Patients' Rights in Cross-border Healthcare directive in Latvia.

PubMed

Olsena, Solvita

2014-03-01

Latvia, being one of the EU Member States, has an obligation to implement the rules stated by the Directive 2011/24/EU on Patients' Rights in Cross-border Healthcare (hereinafter--the Directive) before 25 October 2013 in existing national legislation and practice. Implementation was carried out under pressured circumstances. A National Contact Point has been established, information is provided for patients in Latvian and to some extent in English, the Medical Treatment Risk Fund will start operations to provide compensation for harm, and the restrictions and procedure for prior authorisation have been stated. The need to secure quality of care and patient safety and well as privacy protection are the most challenging tasks for Latvia. It can be concluded that some progress in patients' rights can be achieved, but it is doubtful if patients' mobility will be stimulated.

Assessing the quality of corporate social responsibility reports: the case of reporting practices in selected European Union member states.

PubMed

Hąbek, Patrycja; Wolniak, Radosław

The organization may communicate its engagement in sustainability and may presents results achieved in this field by creating and publishing corporate social responsibility (CSR) reports. Today, we can observe a growing number of companies issuing such reports as a part of their annual reports or as stand-alone CSR reports. Despite the increase in the number of such reports their quality is different. CSR reports do not always provide complete data that readers desire, which in turn intensifies the problem with the evaluation and comparison of the organization's results achieved in this scope. Differences also occur between reporting models used in different EU countries caused by, inter alia, differently applied EU legislation on the disclosure of non-financial information in different Member States. This paper is one of the first attempts to perform a quantitative and qualitative analysis of corporate sustainability reporting practices in several European Union countries. The purpose of this article is to present the current state of CSR reporting practices in selected EU Member States and identify the differences in the quality and level of this kind of practices, taking into account the mandatory and voluntary model of disclosure. The study included separate CSR reports as well as annual reports with CSR sections and integrated reports published in 2012 in six selected EU Member States. The authors have used a specific evaluation tool in the examination of the individual reports. The assessment questionnaire consists of seventeen criteria grouped into two categories (relevance and credibility of information). In order to assess the quality of examined reports, the authors aggregated the indicators related with the reporting practices. The findings show that the quality level of the studied reports is generally low. Referring to its components, the relevance of the information provided in the assessed reports is at the higher level than its credibility. The study also indicates that the legal obligation of CSR data disclosure has a positive effect on the quality of CSR reports.

Standards, documents of relevance and directives in individual monitoring: is European individual monitoring in compliance with standards?

PubMed

Fantuzzi, E

2007-01-01

Individual monitoring services (IMS) in Europe do not comply with the same legal or approval requirements. Anyway, a degree of harmonisation existing in individual monitoring practices in Europe has been achieved mainly thanks to documents as standards or international recommendations, which with different weight represent invaluable vehicles of condensed information transfer. However, implementation of standards is not straightforward and harmonisation is not directly a consequence. Somehow, 'harmony' is needed also in standards: IEC and ISO standards, on performance requirements for dosemeters sometimes have different approaches (i.e. performance criteria). Moreover, standards do not all refer to reliability, and therefore being in compliance with standards does not by itself assure that dose results are reliable. Standards are not the only reference documents for an IMS. EURADOS working group on 'Harmonisation of Individual Monitoring in Europe', who has been active in the years 2001-2004, suggested a classification of publication on individual monitoring, distinguishing between standards and documents of relevance, which can be both national and international. None of the two categories are mandatory unless specified in legislation. The Council Directive 96/29/EURATOM and its implementation in each EU Member States has fostered harmonisation of the approach (i.e. approval of dosimetric services) and of the reference quantities for individual monitoring within EU, but national legislation still allow substantial differences in individual monitoring from country to country.

Human health safety evaluation of cosmetics in the EU: a legally imposed challenge to science.

PubMed

Pauwels, M; Rogiers, V

2010-03-01

As stated in the European legislation, cosmetic products present on the European market must be safe for the consumer. Safety evaluation of the products is carried out by a qualified safety assessor who needs to consider potential exposure scenarios next to the physicochemical and toxicological profiles of all composing ingredients. Whereas, until recently, the tools to determine the toxicological profile of cosmetic ingredients mainly consisted of animal experiments, they have now been narrowed down substantially by the legally imposed animal testing ban on cosmetic ingredients, taken up in the Cosmetic Products Directive (76/768/EEC). This Directive, however, is not a stand-alone piece of European legislation, since as well directly as indirectly it is influenced by a complex web of related legislations. Vertical legislations deal with different categories of chemicals, including dangerous substances, biocides, plant protection products, food additives, medicinal products, and of course also cosmetics. Horizontal legislative texts, on the contrary, cover more general fields such as protection of experimental animals, consumer product safety, misleading of consumers, specific provisions for aerosols, and others. Experience has learnt that having a general overview of these related legislations is necessary to understand their impact on the cosmetic world in general terms and on cosmetic safety evaluation in particular. This goes for a variety of concerned parties, including national and European regulators/agencies, contract laboratories, raw material suppliers, cosmetic companies, research and educational centers. They all deal with a number of aspects important for the quality and toxicity of cosmetics and their ingredients. This review summarises the most relevant points of the legislative texts of different types of product categories and emphasises their impact on the safety evaluation of cosmetics.

Human health safety evaluation of cosmetics in the EU: A legally imposed challenge to science

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pauwels, M., E-mail: Marleen.Pauwels@vub.ac.b; Rogiers, V.

As stated in the European legislation, cosmetic products present on the European market must be safe for the consumer. Safety evaluation of the products is carried out by a qualified safety assessor who needs to consider potential exposure scenarios next to the physicochemical and toxicological profiles of all composing ingredients. Whereas, until recently, the tools to determine the toxicological profile of cosmetic ingredients mainly consisted of animal experiments, they have now been narrowed down substantially by the legally imposed animal testing ban on cosmetic ingredients, taken up in the Cosmetic Products Directive (76/768/EEC). This Directive, however, is not a stand-alonemore » piece of European legislation, since as well directly as indirectly it is influenced by a complex web of related legislations. Vertical legislations deal with different categories of chemicals, including dangerous substances, biocides, plant protection products, food additives, medicinal products, and of course also cosmetics. Horizontal legislative texts, on the contrary, cover more general fields such as protection of experimental animals, consumer product safety, misleading of consumers, specific provisions for aerosols, and others. Experience has learnt that having a general overview of these related legislations is necessary to understand their impact on the cosmetic world in general terms and on cosmetic safety evaluation in particular. This goes for a variety of concerned parties, including national and European regulators/agencies, contract laboratories, raw material suppliers, cosmetic companies, research and educational centers. They all deal with a number of aspects important for the quality and toxicity of cosmetics and their ingredients. This review summarises the most relevant points of the legislative texts of different types of product categories and emphasises their impact on the safety evaluation of cosmetics.« less

New legal requirements for submission of product information to poisons centres in EU member states.

PubMed

de Groot, Ronald; Brekelmans, Pieter; Desel, Herbert; de Vries, Irma

2018-01-01

In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent "appointed bodies"). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements. Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent "appointed bodies") using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs. Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly. Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on interpretation of legal text and ECHA helpdesk support are planned to be ready at the end of 2018.

Electroluminescence color tuning between green and red from metal-oxide-semiconductor devices fabricated by spin-coating of rare-earth (terbium + europium) organic compounds on silicon

NASA Astrophysics Data System (ADS)

Matsuda, Toshihiro; Hattori, Fumihiro; Iwata, Hideyuki; Ohzone, Takashi

2018-04-01

Color tunable electroluminescence (EL) from metal-oxide-semiconductor devices with the rare-earth elements Tb and Eu is reported. Organic compound liquid sources of (Tb + Ba) and Eu with various Eu/Tb ratios from 0.001 to 0.4 were spin-coated on an n+-Si substrate and annealed to form an oxide insulator layer. The EL spectra had only peaks corresponding to the intrashell Tb3+/Eu3+ transitions in the spectral range from green to red, and the intensity ratio of the peaks was appropriately tuned using the appropriate Eu/Tb ratios in liquid sources. Consequently, the EL emission colors linearly changed from yellowish green to yellowish orange and eventually to reddish orange on the CIE chromaticity diagram. The gate current +I G current also affected the EL colors for the medium-Eu/Tb-ratio device. The structure of the surface insulator films analyzed by cross-sectional transmission electron microscopy (TEM), X-ray diffraction (XRD) analysis, and X-ray photoelectron spectroscopy (XPS) has four layers, namely, (Tb4O7 + Eu2O3), [Tb4O7 + Eu2O3 + (Tb/Eu/Ba)SiO x ], (Tb/Eu/Ba)SiO x , and SiO x -rich oxide. The EL mechanism proposed is that electrons injected from the Si substrate into the SiO x -rich oxide and Tb/Eu/Ba-silicate layers become hot electrons accelerated in a high electric field, and then these hot electrons excite Tb3+ and Eu3+ ions in the Tb4O7/Eu2O3 layers resulting in EL emission from Tb3+ and Eu3+ intrashell transitions.

Analyzing 20 years of Black Carbon measurements in Germany

NASA Astrophysics Data System (ADS)

Kutzner, R. D.; Quedenau, J.; Kuik, F.; von Schneidemesser, E.; Schmale, J.

2016-12-01

Black Carbon (BC) is an important short-lived climate-forcing pollutant contributing to global warming through absorption of sunlight. In addition, BC, as a component of particulate matter (PM) exerts adverse health effects. Anthropogenic emission sources of BC include residential heating, transport, and agricultural fires, and the dominant natural emission source is wildfires. Despite the adverse effects of BC, legislation that requires mandatory monitoring of BC concentrations does not currently exist in the European Union (EU). Instead, BC is only indirectly monitored as component of PM10 and PM2.5 (PM with a diameter smaller 10 µm and 2.5 µm, respectively). Before the introduction of mandatory PM10 and PM2.5 monitoring in the EU in 2005 and 2015, respectively, `black smoke' (BS), a surrogate for BC, was a required measurement in Germany from the early 1990s. The annual mean limit value was 14 µg/m3 from 1995 and 8 µg/m³ from 1998. In 2004, many measurements were stopped, with the repeal of the regulations. In most German federal states a limited number BC monitoring stations continued to operate. We present a synthesis of BC data from 213 stations across Germany covering the period between 1994 and 2014. Due to the lack of a standardized method and respective legislation, the data set is very heterogeneous relying on twelve different measurement methods including chemical, optical, and thermal-optical methods. Stations include, among others, urban background, traffic and rural. We highlight results from the year 2009, as it is the year with the largest measurement coverage based on the same measurement method, with 28 stations. Further, we calculated trends in BC concentrations for 13 stations with at least 10 years of data, for median concentrations, as well as 5th percentile (background) and 95th percentile (peak episodes). Preliminary results suggest that concentrations have generally declined, with a larger trend at traffic stations compared to urban background stations between 2005 and 2014. However, preliminary results also show that concentrations are highest during the colder months, likely linked to residential heating.

Research on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach.

PubMed

Dumez, Birgit; Van Damme, Karel; Casteleyn, Ludwine

2008-06-05

Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed.This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework.These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP).

Research on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach

PubMed Central

Dumez, Birgit; Van Damme, Karel; Casteleyn, Ludwine

2008-01-01

Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed. This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework. These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP). PMID:18541073

Collaboration of the Joint Research Centre and the European Customs laboratories for Identification of New Psychoactive Substances.

PubMed

Guillou, Claude; Reniero, Fabiano; Vicente, Joana Lobo Pereira; Holland, Margaret; Kolar, Kamil; Chassaigne, Hubert; Tirendi, Salvatore; Schepers, Herve

2018-05-23

The emergence of designer drugs as substances of abuse has seen a dramatic increase over the last few years. Customs officials are responsible for the control of products entering the European Union (EU) market. This control applies to chemicals in general, pharmaceutical products and medicines. Numerous products imported from non-EU countries, often -declared as 'bath salts' or 'fertilizers', may in fact contain new psychoactive substance (NPS). These are not necessarily controlled under international law, but are subject to monitoring in agreement with EU legislation. This situation imposes many challenges for the maintenance of updated spectral libraries used for their detection by control laboratories. The chemical identification of new substances, with the use of powerful instrumentation, and the time needed for detailed analysis and interpretation of the results, demands a considerable scientific commitment. The Joint Research Centre endeavors to provide this through its scientific support to the EU Customs laboratories to facilitate the rapid identification and characterisation of seized samples. Apart from the known NPS, several new chemical substances have also been identified. Those belonging to known NPS families have already been notified to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). The aim of this paper is to discuss the implementation of the workflow mechanism, regarding the harmonisation of procedures to facilitate the monitoring, communication and management of analytical data. The rapid dissemination of this information between control authorities would facilitate the protection of EU citizens against the health risks posed by harmful substances. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Acrylamide: formation, occurrence in food products, detection methods, and legislation.

PubMed

Arvanitoyannis, Ioannis S; Dionisopoulou, Niki

2014-01-01

This review aims at summarizing the most recent updates in the field of acrylamide (AA) formation (mechanism, conditions) and the determination of AA in a number of foods (fried or baked potatoes, chips, coffee, bread, etc). The methods applied for AA detection [Capillary Electrophoresis-Mass Spectrometry (CE-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Non-Aqueous Capillary Electrophoresis (NACE), High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS), Pressurized Fluid Extraction (PFE), Matrix Solid-Phase Dispersion (MSPD), Gas Chromatography-Mass Spectrometry (GC-MS), Solid-Phase MicroExtraction-Gas Chromatography (SPME-GC), Enzyme Linked Immunosorbent Assay (ELISA), and MicroEmulsion ElectroKinetic Chromatography (MEEKC) are presented and commented. Several informative figures and tables are included to show the effect of conditions (temperature, time) on the AA formation. A section is also included related to AA legislation in EU and US.

Health and safety strategies in a changing Europe.

PubMed

Walters, D

1998-01-01

This article presents a synthesis of some of the more significant findings from two recent surveys on working conditions and national strategies for their improvement in the European Union in the 1990s. As patterns and organization of employment have changed in the past decade, the consequences for health and safety present new challenges for legislators, the social partners, the regulatory agencies, and the specialists. These challenges are only partially met in most European member states. Because of the continued deregulation of employment, reduced public expenditure, and reduced trade union presence, the operation of strategies to implement a common framework of E.U. legislation is limited and often incomplete. This issue must be confronted if systems for promoting the well-being of people at work in Europe are to keep up with the rapidly changing nature of the risks that they face.

SWOT analysis of the renewable energy sources in Romania - case study: solar energy

NASA Astrophysics Data System (ADS)

Lupu, A. G.; Dumencu, A.; Atanasiu, M. V.; Panaite, C. E.; Dumitrașcu, Gh; Popescu, A.

2016-08-01

The evolution of energy sector worldwide triggered intense preoccupation on both finding alternative renewable energy sources and environmental issues. Romania is considered to have technological potential and geographical location suitable to renewable energy usage for electricity generation. But this high potential is not fully exploited in the context of policies and regulations adopted globally, and more specific, European Union (EU) environmental and energy strategies and legislation related to renewable energy sources. This SWOT analysis of solar energy source presents the state of the art, potential and future prospects for development of renewable energy in Romania. The analysis concluded that the development of solar energy sector in Romania depends largely on: viability of legislative framework on renewable energy sources, increased subsidies for solar R&D, simplified methodology of green certificates, and educating the public, investors, developers and decision-makers.

Defining Chlorophyll-a Reference Conditions in European Lakes

PubMed Central

Alves, Maria Helena; Argillier, Christine; van den Berg, Marcel; Buzzi, Fabio; Hoehn, Eberhard; de Hoyos, Caridad; Karottki, Ivan; Laplace-Treyture, Christophe; Solheim, Anne Lyche; Ortiz-Casas, José; Ott, Ingmar; Phillips, Geoff; Pilke, Ansa; Pádua, João; Remec-Rekar, Spela; Riedmüller, Ursula; Schaumburg, Jochen; Serrano, Maria Luisa; Soszka, Hanna; Tierney, Deirdre; Urbanič, Gorazd; Wolfram, Georg

2010-01-01

The concept of “reference conditions” describes the benchmark against which current conditions are compared when assessing the status of water bodies. In this paper we focus on the establishment of reference conditions for European lakes according to a phytoplankton biomass indicator—the concentration of chlorophyll-a. A mostly spatial approach (selection of existing lakes with no or minor human impact) was used to set the reference conditions for chlorophyll-a values, supplemented by historical data, paleolimnological investigations and modelling. The work resulted in definition of reference conditions and the boundary between “high” and “good” status for 15 main lake types and five ecoregions of Europe: Alpine, Atlantic, Central/Baltic, Mediterranean, and Northern. Additionally, empirical models were developed for estimating site-specific reference chlorophyll-a concentrations from a set of potential predictor variables. The results were recently formulated into the EU legislation, marking the first attempt in international water policy to move from chemical quality standards to ecological quality targets. PMID:20401659

EU Laws on Privacy in Genomic Databases and Biobanking.

PubMed

Townend, David

2016-03-01

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be "fair and lawful" and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only for so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification (anonymization) of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data. © 2016 American Society of Law, Medicine & Ethics.

Thirty years of European biotechnology programmes: from biomolecular engineering to the bioeconomy.

PubMed

Aguilar, Alfredo; Magnien, Etienne; Thomas, Daniel

2013-06-25

This article traces back thirty years of biotechnology research sponsored by the European Union (EU). It outlines the crucial role played by De Nettancourt, Goffeau and Van Hoeck to promote and prepare the first European programme on biotechnology (1982-1986) run by the European Commission. Following this first biotechnology programme, others followed until the current one, part of the seventh Framework Programme for Research, Technological Development and Demonstration (2007-2013) (FP7). Particular attention is given to the statutory role of the European institutions in the design and orientation of the successive biotechnology programmes, compared to the more informal-yet visionary-role of key individuals upstream to any legislative decision. Examples of success stories and of the role of the biotechnology programmes in addressing societal issues and industrial competitiveness are also presented. Finally, an outline of Horizon 2020, the successor of FP7, is described, together with the role of biotechnology in building the bioeconomy. Copyright © 2012 Elsevier B.V. All rights reserved.

A regulatory perspective on the radiological impact of NORM industries: the case of the Spanish phosphate industry.

PubMed

García-Talavera, M; Matarranz, J L M; Salas, R; Ramos, L

2011-01-01

Radioactive and chemical risks coexist in NORM industries although they are usually addressed separately by regulations. The European Union (EU) has developed extensive legislation concerning both matters, which has been diversely reflected in national policies. We consider the case of the Spanish phosphate industry and analyse to which extent regulatory mandates have reduced the historical and ongoing radiological impact on the environment of phosphate facilities. Although no specific radiological constraints on effluent monitoring and release or on waste disposal have yet been imposed on NORM industries in Spain, other environmental regulations have achieved a substantial reduction on the phosphate industry impact. Nevertheless, a more efficient control could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks in NORM industries. We highlight research needs to accomplish so and propose shorter-term measures that require active cooperation among the regulatory bodies involved. Copyright © 2010. Published by Elsevier Ltd.

The Austrian radon activities on the way to the national radon action plan.

PubMed

Gruber, V; Ringer, W; Wurm, G; Haider, W

2014-07-01

Based on the new Euratom Basic Safety Standards (BSS), all EU member states will be obliged to design a strategy to address long-term risks from radon exposure, which is laid down in the 'national radon action plan'. In Austria, the National Radon Centre is responsible for the development of the action plan. This paper presents the current and planned radon protection activities on the way to establish the radon action plan--like the national radon database, the definition of radon risk areas by improving the existing radon map, as well as strategies and activities to increase the radon awareness of the public and decision-makers and to involve the building sector. The impact of and the need for actions caused by the BSS requirements on the Austrian radon legislation, strategy and programme are discussed. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Developing a biomonitoring tool for fine sediment

NASA Astrophysics Data System (ADS)

Turley, Matt; Bilotta, Gary; Brazier, Richard; Extence, Chris

2014-05-01

Sediment is an essential component of freshwater ecosystems; however anthropogenic activities can lead to elevated sediment delivery which can impact on the physical, chemical and biological characteristics of these ecosystems. Ultimately, this can result in a loss of ecosystem services worth more than 1.7 trillion per annum. As such it is important that sediment, which is one of the most commonly attributed causes of water quality impairment globally, is managed in order to minimise these impacts. The current EU environmental quality standard for sediment (monitored in the form of suspended solids) is 25 mg L-1 for all environments. It is widely recognised that this standard is unsuitable and not ecologically relevant. Furthermore, it requires a substantial resource investment to monitor sediment in this form as part of national and international water resource legislation. In recognition of this the development of sediment-specific biomonitoring tools is receiving increasing attention. The Proportion of Sediment-Sensitive Invertebrates (PSI) index is one such tool that is designed to indicate levels of fine sediment (

Groundwater protection of minimal water supply systems integrating simple hydrogeological information

NASA Astrophysics Data System (ADS)

Rodrigo-Ilarri, Javier; Rodrigo-Clavero, María Elena

2016-04-01

According to the current EU environmental legislation, groundwater protection is one of the key issues to be addressed when new industrial activities have to be authorised. This work shows a simple methodology that could be used by local and environmental authorities in order to analyse the potential risk caused by an industrial spill on a natural environment. The methodology leads to the determination of the protection area around an extraction well system using the information given by: i) a set of local piezometers, ii) the chemical nature of the industrial spill and iii) the hydrogeological parameters of the local aquifer. The exact location of the contaminant source is not needed for the analysis. The flow equation is afterwards solved using a finite-difference approximation scheme under stationary conditions. Finally, the capture zones for different times are computed by a simple upstream advective transport model. Results on the determination of the perimeter protection area definition of a water supply system in the municipality of L'Alcora (Castellón) in Spain are shown.

Is there a right to donate blood? Patient rights; donor responsibilities.

PubMed

Franklin, Ian M

2007-06-01

The objective of this study was to analyse and assess critically whether there is a right to donate blood in the UK. The aim was to provide a basis for blood services, in particular within the UK and European Union (EU), to address claims from deferred donors that there is a right to donate. Recent and ongoing campaigns to change the current life-long deferral from blood donation in the UK, Canada and USA of men who have/have had sex with men (MSM) have highlighted issues over whether individuals have a right to donate blood. The issue is complicated by allegations of discriminatory behaviour, and in some countries politicians have contributed to the argument. As anti-discrimination and equality legislation is strengthened in the UK, other groups in addition to MSM may wish to claim a right to donate blood. The methods adopted included discussions with colleagues in UK and European blood services and a review of the medical literature and wider sources using Internet search engines. No clear right to donate blood is apparent, although it is recommended that donor deferral criteria should have a sound basis of evidence. Potential donors have a right to expect a clear explanation of the reason(s) for refusing a donation. Legal safeguards for recipients to receive safe blood transfusions exist. It is concluded that blood recipients in the EU have a right to receive safe blood, and that this should be viewed as the overriding responsibility of blood services.

Recovery of Anisakid larvae by means of chloro-peptic digestion and proposal of the method for the official control.

PubMed

Fraulo, Pasquale; Morena, Carmelo; Costa, Antonella

2014-10-01

Anisakidae larvae belonging to the genera Anisakis and Pseudoterranova, are the most responsible for zoonosis transmitted by fish products (anisakidosis). Acquired by the consumption of raw or undercooked marine fish or squid, the anisakid larvae may cause pathogenic diseases like gastric or intestinal anisakiasis and gastro-allergic disorders. In accordance with current EU legislation, the fresh fish products must be inspected visually in order to detect the possible presence of visible parasites. It is recognized that the visual method is not accurate enough to detect the larvae of parasites in food preparations containing raw or practically raw seafood and it clearly emerges that the official system of control needs to be able to utilise an most efficient analytical technique. In this work, the authors have drawn up and validated an analytical method, which involves artificial digestion and the use of a heated magnetic stirrer, based on the EU Regulation n. 2075/2005. The larvae isolated are then subjected to morphological identification at genus level by using optical microscope. The method, proved to be suitable for the detection of live and dead larvae of anisakidae in ready-to-eat foodstuffs containing raw fish or cephalopods and it is fast and accurate. The method showed high levels of sensitivity and specificity, and the suitability of its use in official food control was confirmed. Its use should be incorporated systematically into specific monitoring programs for the control of foodstuffs containing raw fish products.

Electronic Health Record in Italy and Personal Data Protection.

PubMed

Bologna, Silvio; Bellavista, Alessandro; Corso, Pietro Paolo; Zangara, Gianluca

2016-06-01

The present article deals with the Italian Electronic Health Record (hereinafter EHR), recently introduced by Act 221/2012, with a specific focus on personal data protection. Privacy issues--e.g., informed consent, data processing, patients' rights and minors' will--are discussed within the framework of recent e-Health legislation, national Data Protection Code, the related Data Protection Authority pronouncements and EU law. The paper is aimed at discussing the problems arising from a complex, fragmentary and sometimes uncertain legal framework on e-Health.

Public health concern behind the exposure to persistent organic pollutants and the risk of metabolic diseases.

PubMed

Ruzzin, Jérôme

2012-04-20

Persistent organic pollutants (POPs) are hazardous chemicals omnipresent in our food chain, which have been internationally regulated to ensure public health. Initially described for their potency to affect reproduction and promote cancer, recent studies have highlighted an unexpected implication of POPs in the development of metabolic diseases like type 2 diabetes and obesity. Based on this novel knowledge, this article aims at stimulating discussion and evaluating the effectiveness of current POP legislation to protect humans against the risk of metabolic diseases. Furthermore, the regulation of POPs in animal food products in the European Union (EU) is addressed, with a special focus on marine food since it may represent a major source of POP exposure to humans. There is mounting scientific evidence showing that current POP risk assessment and regulation cannot effectively protect humans against metabolic disorders. Better regulatory control of POPs in dietary products should be of high public health priority. The general population is exposed to sufficient POPs, both in term of concentration and diversity, to induce metabolic disorders. This situation should attract the greatest attention from the public health and governmental authorities.

Problems of Technology of Energy-Saving Buildings and Their Impact on Energy Efficiency in Buildings

NASA Astrophysics Data System (ADS)

Kwasnowski, Pawel; Fedorczak-Cisak, Malgorzata; Knap, Katarzyna

2017-10-01

Introduction of EPBD in legislation of the EU member states caused that buildings must meet very stringent requirements of thermal protection and energy efficiency. On the basis of EPBD provisions, EU Member States introduce standard of NZEB (Nearly Zero-Energy Buildings). Such activities cause a need for new, innovative materials and technologies, and new approaches to design, construction and retrofitting of buildings. Indispensable is the precise coordination of the design of structure and technical installations of building, which may be provided in an integrated design process in the system BIM. Good coordination and cooperation of all contractors during the construction phase is also necessary. The article presents the problems and the new methodology for the design, construction and use of energy efficient buildings in terms of energy saving technologies, including discussion of the significant impact of the automation of technical installations on the building energy efficiency.

Subnational responsibilities for healthcare and Austria's rejection of the EU's patients' rights directive.

PubMed

Kostera, Thomas

2013-07-01

In 2011, Member States and the European Parliament brought into force a Directive on the application of patients' rights in cross-border healthcare within the EU. Austria voted against this directive even though its national legislation was already in line with the rulings of the European Court of Justice which had triggered the negotiations on the directive. Why then, in the absence of any legal constraints on adapting to it, did Austria vote against the directive? The article argues that it was the federal structure of financing hospital infrastructure and the subnational level's influence on national position building which led to the rejection of the directive. The article retraces the process of position building by analyzing the interaction between the national and the subnational levels and concludes that Austria's position mirrors the national struggle between both levels of government over control of the hospital sector. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The EU Physical Agents (EMF) Directive and its impact on MRI imaging in animal experiments: a submission by FRAME to the HSE.

PubMed

Hudson, Michelle

2006-06-01

The EU Physical Agents (EMF) Directive, Directive 2004/40/EC, which threatens to greatly restrict the use of magnetic resonance imaging (MRI) in both clinical and research situations, will come into force on 30 April 2008. This could severely affect experimental animal welfare and scientific progress, as well as patient care. FRAME made a submission to a Health and Safety Executive round-table discussion about the Directive, held in January 2006, detailing concerns about the implications that the legislation would have on implementing the Three Rs in animal-based research and testing, and the subsequent consequences for animal welfare and the quality of scientific output. The submission is reproduced here, with additional comments on the outcome of the meeting and recommendations for further research into the consequences of the Directive.

Regulatory Anatomy: How "Safety Logics" Structure European Transplant Medicine.

PubMed

Hoeyer, Klaus

2015-07-01

This article proposes the term "safety logics" to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of "safety" produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

[EU law on marketing authorization of medicines. History, current state of development and perspectives].

PubMed

Nettesheim, Martin

2008-07-01

The article describes the development of EU policies and regulations on the marketing authorization of medicines. First, it describes the changing perspective of the EU towards the regulation of such authorizations. While its original focus was on the liberalization of national markets, it has today assumed overarching political responsibility for the development and marketing of medicines. Second, the article describes the current, rather fragmented regulatory system. Finally, political perspectives on the integration of markets for medicines are developed.

A new framework proposal, towards a common EU agricultural policy, with the best sustainable practices for the re-use of olive mill wastewater.

PubMed

Koutsos, T M; Chatzistathis, T; Balampekou, E I

2018-05-01

The disposal of olive mill wastewater (OMW) is a serious environmental issue for the Mediterranean countries. However, there is still no common European legislation on the management and the re-use of OMW in agriculture, in the frame of sustainable crop management and the standards for the safe OMW disposal and re-use are left to be set by each EU country, individually. This review paper presents the most effective and sustainable practices for OMW, (treatment, application and management), which can maximize the benefits of OMW on crops and soils, while minimizing the potential hazards for public health, thus promoting environmental sustainability. The findings of this synthetic work suggest that there is enough information and proven sustainable practices to go ahead with the initial formulation of a new consensual framework, environmentally acceptable, socially bearable and economically viable, that could hopefully help to set the standards for the re-use of olive mil wastewater and can lead to a common EU policy on the management and re-use of OMW. Copyright © 2017 Elsevier B.V. All rights reserved.

Science-based approach for credible accounting of mitigation in managed forests.

PubMed

Grassi, Giacomo; Pilli, Roberto; House, Jo; Federici, Sandro; Kurz, Werner A

2018-05-17

The credibility and effectiveness of country climate targets under the Paris Agreement requires that, in all greenhouse gas (GHG) sectors, the accounted mitigation outcomes reflect genuine deviations from the type and magnitude of activities generating emissions in the base year or baseline. This is challenging for the forestry sector, as the future net emissions can change irrespective of actual management activities, because of age-related stand dynamics resulting from past management and natural disturbances. The solution implemented under the Kyoto Protocol (2013-2020) was accounting mitigation as deviation from a projected (forward-looking) "forest reference level", which considered the age-related dynamics but also allowed including the assumed future implementation of approved policies. This caused controversies, as unverifiable counterfactual scenarios with inflated future harvest could lead to credits where no change in management has actually occurred, or conversely, failing to reflect in the accounts a policy-driven increase in net emissions. Instead, here we describe an approach to set reference levels based on the projected continuation of documented historical forest management practice, i.e. reflecting age-related dynamics but not the future impact of policies. We illustrate a possible method to implement this approach at the level of the European Union (EU) using the Carbon Budget Model. Using EU country data, we show that forest sinks between 2013 and 2016 were greater than that assumed in the 2013-2020 EU reference level under the Kyoto Protocol, which would lead to credits of 110-120 Mt CO 2 /year (capped at 70-80 Mt CO 2 /year, equivalent to 1.3% of 1990 EU total emissions). By modelling the continuation of management practice documented historically (2000-2009), we show that these credits are mostly due to the inclusion in the reference levels of policy-assumed harvest increases that never materialized. With our proposed approach, harvest is expected to increase (12% in 2030 at EU-level, relative to 2000-2009), but more slowly than in current forest reference levels, and only because of age-related dynamics, i.e. increased growing stocks in maturing forests. Our science-based approach, compatible with the EU post-2020 climate legislation, helps to ensure that only genuine deviations from the continuation of historically documented forest management practices are accounted toward climate targets, therefore enhancing the consistency and comparability across GHG sectors. It provides flexibility for countries to increase harvest in future reference levels when justified by age-related dynamics. It offers a policy-neutral solution to the polarized debate on forest accounting (especially on bioenergy) and supports the credibility of forest sector mitigation under the Paris Agreement.

A case study of polypharmacy management in nine European countries: Implications for change management and implementation

PubMed Central

MacLure, Katie; Stewart, Derek; Kempen, Thomas; Mair, Alpana; Castel-Branco, Margarida; Codina, Carles; Fernandez-Llimos, Fernando; Fleming, Glenda; Gennimata, Dimitra; Gillespie, Ulrika; Harrison, Cathy; Illario, Maddalena; Junius-Walker, Ulrike; Kampolis, Christos F.; Kardas, Przemyslaw; Lewek, Pawel; Malva, João; Menditto, Enrica; Scullin, Claire; Wiese, Birgitt

2018-01-01

Background Multimorbidity and its associated polypharmacy contribute to an increase in adverse drug events, hospitalizations, and healthcare spending. This study aimed to address: what exists regarding polypharmacy management in the European Union (EU); why programs were, or were not, developed; and, how identified initiatives were developed, implemented, and sustained. Methods Change management principles (Kotter) and normalization process theory (NPT) informed data collection and analysis. Nine case studies were conducted in eight EU countries: Germany (Lower Saxony), Greece, Italy (Campania), Poland, Portugal, Spain (Catalonia), Sweden (Uppsala), and the United Kingdom (Northern Ireland and Scotland). The workflow included a review of country/region specific polypharmacy policies, key informant interviews with stakeholders involved in policy development and implementation and, focus groups of clinicians and managers. Data were analyzed using thematic analysis of individual cases and framework analysis across cases. Results Polypharmacy initiatives were identified in five regions (Catalonia, Lower Saxony, Northern Ireland, Scotland, and Uppsala) and included all care settings. There was agreement, even in cases without initiatives, that polypharmacy is a significant issue to address. Common themes regarding the development and implementation of polypharmacy management initiatives were: locally adapted solutions, organizational culture supporting innovation and teamwork, adequate workforce training, multidisciplinary teams, changes in workflow, redefinition of roles and responsibilities of professionals, policies and legislation supporting the initiative, and data management and information and communication systems to assist development and implementation. Depending on the setting, these were considered either facilitators or barriers to implementation. Conclusion Within the studied EU countries, polypharmacy management was not widely addressed. These results highlight the importance of change management and theory-based implementation strategies, and provide examples of polypharmacy management initiatives that can assist managers and policymakers in developing new programs or scaling up existing ones, particularly in places currently lacking such initiatives. PMID:29668763

EU alerting and reporting systems for potential chemical public health threats and hazards.

PubMed

Orford, R; Crabbe, H; Hague, C; Schaper, A; Duarte-Davidson, R

2014-11-01

A number of European and international IT platforms are used to notify competent authorities of new potential chemical exposures. Recently the European Parliament and the Council of European Union adopted new legislation that aims to improve the co-ordinated response to cross border health threats (Decision 1082/2013/EU). The Decision, inter alia, sets provisions on notification, ad hoc monitoring and coordination of public health measures following serious cross border threats to health from biological, chemical and environmental events as well as events that have an unknown origin. The legal instrument applies to all European Union Member States and is comparable to the International Health Regulations in its content, requirements and adoption of a multiple hazards approach. An inter-sectoral and multidisciplinary response to events with potentially dangerous cross border exposure pathways is often required. For example, European Poisons Centres may be aware of cases of toxic exposure to a product and, in parallel, trading standards may be aware of the same product due to a breach of consumer product standards. Whilst both cases would have been recorded for separate purposes in different alerting systems, they relate to the same exposure pathway; therefore a process for linking these records would allow a more robust approach to risk assessment and risk mitigation. The Decision seeks to reconcile this issue for serious threats by linking relevant platforms into one overarching higher level risk management IT platform called the Early Warning Response System (EWRS). This system will serve to link other sectors within the European Commission (EC) to public health (e.g. medicines), as well as other EU agencies and international bodies via co-notification features. Other European alert systems will be linked to EWRS to facilitate information sharing at both the assessment and management levels. This paper provides a timely overview of the main systems run by the EC and other international organisations that provide alerts following chemical incidents that have, or may have, the potential to affect public health. The advantages and further considerations of linking these different systems and sectors are also highlighted. Recommendations are made with the purpose of ensuring that modifications to these systems made to satisfy with EU legislation enable a more timely coordinated response and greater awareness of events in Europe, thereby reducing the public health impact from chemical exposures. Copyright © 2014 Elsevier Ltd. All rights reserved.

Fusarium graminearum in Stored Wheat: Use of CO2 Production to Quantify Dry Matter Losses and Relate This to Relative Risks of Zearalenone Contamination under Interacting Environmental Conditions

PubMed Central

Kiaitsi, Elsa; Magan, Naresh

2018-01-01

Zearalenone (ZEN) contamination from Fusarium graminearum colonization is particularly important in food and feed wheat, especially during post-harvest storage with legislative limits for both food and feed grain. Indicators of the relative risk from exceeding these limits would be useful. We examined the effect of different water activities (aw; 0.95–0.90) and temperature (10–25 °C) in naturally contaminated and irradiated wheat grain, both inoculated with F. graminearum and stored for 15 days on (a) respiration rate; (b) dry matter losses (DML); (c) ZEN production and (d) relationship between DML and ZEN contamination relative to the EU legislative limits. Gas Chromatography was used to measure the temporal respiration rates and the total accumulated CO2 production. There was an increase in temporal CO2 production rates in wetter and warmer conditions in all treatments, with the highest respiration in the 25 °C × 0.95 aw treatments + F. graminearum inoculation. This was reflected in the total accumulated CO2 in the treatments. The maximum DMLs were in the 0.95 aw/20–25 °C treatments and at 10 °C/0.95 aw. The DMLs were modelled to produce contour maps of the environmental conditions resulting in maximum/minimum losses. Contamination with ZEN/ZEN-related compounds were quantified. Maximum production was at 25 °C/0.95–0.93 aw and 20 °C/0.95 aw. ZEN contamination levels plotted against DMLs for all the treatments showed that at ca. <1.0% DML, there was a low risk of ZEN contamination exceeding EU legislative limits, while at >1.0% DML, the risk was high. This type of data is important in building a database for the development of a post-harvest decision support system for relative risks of different mycotoxins. PMID:29462982

Fusarium graminearum in Stored Wheat: Use of CO₂ Production to Quantify Dry Matter Losses and Relate This to Relative Risks of Zearalenone Contamination under Interacting Environmental Conditions.

PubMed

Garcia-Cela, Esther; Kiaitsi, Elsa; Sulyok, Michael; Medina, Angel; Magan, Naresh

2018-02-17

Zearalenone (ZEN) contamination from Fusarium graminearum colonization is particularly important in food and feed wheat, especially during post-harvest storage with legislative limits for both food and feed grain. Indicators of the relative risk from exceeding these limits would be useful. We examined the effect of different water activities (a w ; 0.95-0.90) and temperature (10-25 °C) in naturally contaminated and irradiated wheat grain, both inoculated with F. graminearum and stored for 15 days on (a) respiration rate; (b) dry matter losses (DML); (c) ZEN production and (d) relationship between DML and ZEN contamination relative to the EU legislative limits. Gas Chromatography was used to measure the temporal respiration rates and the total accumulated CO₂ production. There was an increase in temporal CO₂ production rates in wetter and warmer conditions in all treatments, with the highest respiration in the 25 °C × 0.95 a w treatments + F. graminearum inoculation. This was reflected in the total accumulated CO₂ in the treatments. The maximum DMLs were in the 0.95 a w /20-25 °C treatments and at 10 °C/0.95 a w . The DMLs were modelled to produce contour maps of the environmental conditions resulting in maximum/minimum losses. Contamination with ZEN/ZEN-related compounds were quantified. Maximum production was at 25 °C/0.95-0.93 a w and 20 °C/0.95 a w . ZEN contamination levels plotted against DMLs for all the treatments showed that at ca <1.0% DML, there was a low risk of ZEN contamination exceeding EU legislative limits, while at >1.0% DML, the risk was high. This type of data is important in building a database for the development of a post-harvest decision support system for relative risks of different mycotoxins.

[Animal feeding and feed legislation after the detection of the first indigenous BSE cases in Germany].

PubMed

Kamphues, J

2002-08-01

In Great Britain, even the earliest tangible signs indicating the epidemiologic significance of meat and bone meal in the spreading of BSE soon gave rise to increasingly rigorous legislative measures regulating animal feedstuffs. In 1994 a ban on the feeding of animal proteins to ruminants was implemented throughout the entire EU. But until the first BSE cases were actually confirmed in locally raised cattle (November 2000), feeding practice and legislation more or less in Germany remained unaffected by the efforts undertaken in Great Britain. This situation was suddenly changed on 1 December, 2000, when the so-called "Verfütterungsverbot" was put into effect, a law which drastically extended bans regarding the feedstuffs (including fishmeal and animal fats) as well as the species concerned (all animals used in food production). In 2001 the "contamination" phenomenon (ingredients of animal origin were detected in mixed feeds) became a vital issue for the feed industry; through the media, the subject "feedstuff safety" gained a previously unseen level of public awareness. Those circles concerned with mixed feed production and animal husbandry were increasingly confronted with the consequences of the "Verfütterungsverbot" (availability and pricing of substitute ingredients; the demand for amino acids and inorganic sources of phosphorus; problems finding adequate substitutes for animal fats; poor digestibility of alternative components such as indigenous legumes or vegetable fats in calf diets; lower utilization rate of original phosphorus in mixed feeds with negative consequences for skeletal development). With the conditional approval of fishmeal (except in feeds for ruminants) the situation has eased again to a certain degree; on the EU level there are increasing signals pointing toward a political intention to reinstate the utilization of by-products of slaughtered animals qualified for human consumption (with the exception of fallen/dead animals and specific risk material) in poultry and swine feeding. In Germany, at least, the question of animal fat utilization for food-producing animals is still unsolved.

Biodiversity funds and conservation needs in the EU under climate change

PubMed Central

Lung, Tobias; Meller, Laura; van Teeffelen, Astrid J.A.; Thuiller, Wilfried; Cabeza, Mar

2014-01-01

Despite ambitious biodiversity policy goals, less than a fifth of the European Union’s (EU) legally protected species and habitats show a favorable conservation status. The recent EU biodiversity strategy recognizes that climate change adds to the challenge of halting biodiversity loss, and that an optimal distribution of financial resources is needed. Here, we analyze recent EU biodiversity funding from a climate change perspective. We compare the allocation of funds to the distribution of both current conservation priorities (within and beyond Natura 2000) and future conservation needs at the level of NUTS-2 regions, using modelled bird distributions as indicators of conservation value. We find that funding is reasonably well aligned with current conservation efforts but poorly fit with future needs under climate change, indicating obstacles for implementing adaptation measures. We suggest revising EU biodiversity funding instruments for the 2014-2020 budget period to better account for potential climate change impacts on biodiversity. PMID:25264456

Biodiversity funds and conservation needs in the EU under climate change.

PubMed

Lung, Tobias; Meller, Laura; van Teeffelen, Astrid J A; Thuiller, Wilfried; Cabeza, Mar

2014-07-01

Despite ambitious biodiversity policy goals, less than a fifth of the European Union's (EU) legally protected species and habitats show a favorable conservation status. The recent EU biodiversity strategy recognizes that climate change adds to the challenge of halting biodiversity loss, and that an optimal distribution of financial resources is needed. Here, we analyze recent EU biodiversity funding from a climate change perspective. We compare the allocation of funds to the distribution of both current conservation priorities (within and beyond Natura 2000) and future conservation needs at the level of NUTS-2 regions, using modelled bird distributions as indicators of conservation value. We find that funding is reasonably well aligned with current conservation efforts but poorly fit with future needs under climate change, indicating obstacles for implementing adaptation measures. We suggest revising EU biodiversity funding instruments for the 2014-2020 budget period to better account for potential climate change impacts on biodiversity.

Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

PubMed

Vujić, Mario; Pollak, Lea

2015-12-01

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

The impact of the EU Directive on patients' rights and cross border health care in Malta.

PubMed

Azzopardi-Muscat, Natasha; Aluttis, Christoph; Sorensen, Kristine; Pace, Roderick; Brand, Helmut

2015-10-01

The patients' rights and cross-border health care directive was implemented in Malta in 2013. Malta's transposition of the directive used the discretionary elements allowable to retain national control on cross-border care to the fullest extent. This paper seeks to analyse the underlying dynamics of this directive on the Maltese health care system through the lens of key health system stakeholders. Thirty-three interviews were conducted. Qualitative content analysis of the interviews reveals six key themes: fear from the potential impact of increased patient mobility, strategies employed for damage control, opportunities exploited for health system reform, moderate enhancement of patients' rights, negligible additional patient mobility and unforeseen health system reforms. The findings indicate that local stakeholders expected the directive to have significant negative effects and adopted measures to minimise these effects. In practice the directive has not affected patient mobility in Malta in the first months following its implementation. Government appears to have instrumentalised the implementation of the directive to implement certain reforms including legislation on patients' rights, a health benefits package and compulsory indemnity insurance. Whilst the Maltese geo-demographic situation precludes automatic generalisation of the conclusions from this case study to other Member States, the findings serve to advance our understanding of the mechanisms through which European legislation on health services is influencing health systems, particularly in small EU Member States. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Occupational noise exposure of nightclub bar employees in Ireland.

PubMed

Kelly, Aoife C; Boyd, Sara M; Henehan, Gary T M; Chambers, Gordon

2012-01-01

Due to the transposition of the EU Directive 2003/10/EC into Irish Law, the entertainment sector was obligated to comply with the requirements of the Safety, Health and Welfare at Work (General Application) Regulations 2007, Chapter 1 Part 5: Control of Noise at Work since February 2008. Compliance with the Noise Regulations was examined in 9 nightclubs in Ireland. The typical daily noise exposure of 19 bar employees was measured using 2 logging dosimeters and a Type 1 fixed position sound level meter. Physical site inspections identified nightclub noise control measures. Interviews and questionnaires were used to assess the managers and employees awareness of the noise legislation. The average bar employee daily noise exposure (L(EX, 8h)) was 92 dBA, almost 4 times more than the accepted legal limit. None of the venues examined were fully compliant with the requirements of the 2007 Noise Regulations, and awareness of this legislation was limited.

Development of the competitive business in the context of environmental legislation in Croatia.

PubMed

Matesić, Mirjana; Kalambura, Sanja; Bacun, Dubravka

2014-03-01

Environmental protection has a key role in the context of crisis management. It is not just about development of the industry of environmental protection and implementation of new ways of management in innovative solutions in solving problems. Important area of improvement is also revision of environmental legislation aiming at simplification and reduction of costs of procedures for the business. This paper discusses problems of business sector in Croatia related to transposition of demanding environmental EU regulation, it suggests improvements such as simplification of special waste management systems, of environmental impact assessments processes, environmental permitting etc. The paper considers revision of environmental protection not by lowering environmental standards, but by introducing transparent and compromising models between business and environmental protection, based on sustainable development, with control mechanisms which don't impact functioning of business sector (and its competitiveness), therefore allowing successful protection of environment and its renewable and non-renewable resources.

Regulations applicable to plant food supplements and related products in the European Union.

PubMed

Silano, Vittorio; Coppens, Patrick; Larrañaga-Guetaria, Ainhoa; Minghetti, Paola; Roth-Ehrang, René

2011-12-01

This paper deals with the current regulatory and legal settings of traditional plant food supplements and herbal medicinal products in the European Union (EU). Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, including the use of additives and maximum levels of contaminants and residues. However, due to limited harmonization at the EU level, specific national regulations adopted at a Member State level also apply and mutual recognition is the mechanism through which such products can be marketed in EU countries other than those of origin. Unlike food supplements, marketing of traditional herbal medicinal products is regulated by an ad hoc Directive (i.e. Directive 2004/24/EC) covering in detail all the relevant aspects of these products, including a facilitated registration procedure at national level. However, by distinguishing traditional herbal medicinal products from plant food supplements and establishing selective marketing modalities for these two product categories, the EU has been confronted with implementation difficulties for traditional herbal medicinal products and a lack of homogeneity in the regulatory approaches adopted in different EU Member States. In fact, currently the nature of the commercial botanical products made available to consumers as traditional medicinal products or food supplements, depends largely on the EU Member State under consideration as a consequence of how competent National Authorities and manufacturing companies interpret and apply current regulations rather than on the intrinsic properties of the botanical products and their constituents. When the EU approach is compared with approaches adopted in some non-European countries to regulate these product categories, major differences become evident.

The EU legislation on "GMOs" between nonsense and protectionism: An ongoing Schumpeterian chain of public choices.

PubMed

Tagliabue, Giovanni

2017-01-02

The EU regulation of agricultural biotechnology is botched and convoluted: the pseudo-concept of "Genetically Modified Organisms" has no coherent semantic or scientific content. The reasons of the paradox by which the cultivation of "GMOs" is substantially banned in Europe, while enormous quantities of recombinant-DNA cereals and legumes are imported to be used as feedstuff, are explained. The Directive 2015/412, giving Member states the choice to refuse the cultivation of genetically engineered crops at a national or local level, paves the way for a mosaic-like, Harlequinesque form of protectionism: nothing resembling a well-regulated free market. In the meantime, importation of "GMO" feed goes on at full speed all over Europe. A proposal by the Commission to adjust the rules on importation according to those for cultivation has been rejected by the Parliament.This dynamics may be seen as an ongoing "Schumpeterian" chain of public choices: the calculus of consent drives politicians more than a science-based approach to law-making.  The EU should restart from scratch with the right concept, i.e. the careful examination of the pros and cons, the costs and benefits of each new agricultural product ("GMO" or otherwise), freely cultivated and/or imported, assessed case by case, at last acknowledging that the biotech processes used to create new varieties are of no practical or legal relevance. In doing so, the EU would pursue its stated "better regulation" approach, cancelling any sectoral and sectarian regulation.

Information technology law and health systems in the European Union.

PubMed

Mossialos, Elias; Thomson, Sarah; Ter Linden, Annemarie

2004-01-01

This study aims to examine the impact of European Union (EU) law relating to information technology (IT) on health systems. The study identifies EU directives relating to IT, analyzes them in terms of their impact on the use of IT in health systems, and outlines their implications for health technology assessment (HTA). Analysis is based on a review of literature identified through relevant databases and Internet searches. Developments in IT have serious implications for EU health systems, presenting policy makers with new challenges. The European Commission has adopted a range of legal measures to protect consumers in the "information society" However, as few of them are health-specific, it is not evident that they have implications for health, health systems, or HTA, and they may not be effective in protecting consumers in the health sector. In light of the growing importance of IT in the health sector, legal and nonlegal measures need to be further developed at EU and international level. Where possible, future initiatives should pay attention to the particular characteristics of health goods and services and health systems. Although definitions of HTA usually recognize the importance of evaluating both the indirect, unintended consequences of health technologies and the legal aspects of their application, it seems that, in practice, HTA often overlooks or underestimates legislative matters. Those involved in HTA should be aware of the legal implications of using IT to provide health goods and services and compile, store, transfer, and disseminate health information electronically.

A trans European Union difference in the decline in trans fatty acids in popular foods: a market basket investigation

PubMed Central

Stender, Steen; Astrup, Arne; Dyerberg, Jørn

2012-01-01

Objectives To minimise the intake of industrial trans fatty acids (I-TFA) some countries have introduced labelling, while others have introduced legislative limits on the content of I-TFA in food. However, most countries still rely on food producers to voluntarily reduce the I-TFA content in food. The objective of the present study was to investigate the efficiency of these strategies in the EU. Design The potential consumption of I-TFA was assessed in a market basket investigation by analysing the I-TFA content in popular foods. Setting A standardised purchase methodology was used in 16 EU countries in 2005 and again in 2009. Samples Seventy servings of French fries and chicken nuggets, 90 packages of microwave popcorn, and 442 samples of biscuits/cakes/wafers with ‘partially hydrogenated vegetable fat’ listed high on the list of ingredients were analysed. A high-trans menu was defined as a large serving of French fries and nuggets, 100 g of microwave popcorn and 100 g of biscuits/wafers/cakes. Results In 2005, a high-trans menu provided above 30 g of I-TFA in five EU countries in Eastern Europe and 20–30 g in eight EU countries in Western Europe. In 2009 the values in Hungary, Poland and the Czech Republic remained high between 10 and 20 g, whereas they were less than 2 g in Germany, France and the UK. Conclusions In 2009 contents of I-TFA in popular foods in Western Europe appear low but, in spite of some reduction, still high in Eastern European EU countries. These findings suggest that millions of people in the EU still consume I-TFA in amounts that substantially increase their risk of coronary heart disease. PMID:22986123

Land Recycling: from Science to Practice - A Sustainable Development of Urban Areas

NASA Astrophysics Data System (ADS)

Romanowicz, A.

2015-12-01

Member States (MS) of the European Union have experience significant urban sprawl in the last 3 decades. The urban sprawl was driven mainly by internal (MS or EU) or external migration but also by EU policies (including funds and projects) and by changes in life style (e.g. moving away from cities; second homes). This presentation will aim at showing a number of EU wide analysis on: aging population, depopulation of some of the EU regions; agricultural production and scenarios projections of thereof. Various EU funded projects and programs have analyzed ways how future cities and how EU future land use could developed. Number of those solutions where further investigated with case studies/small scale implementations. However, in recent years the 2012 EU road map to resource efficiency and UN Sustainable Development Goals have called respectively for 'no net land take by 2050' and land neutrality. Thus, the process of implementing innovative solutions for land use has started and some of the cities and regions are well ahead in moving towards XXI century society. In order to streamline/share knowledge and steer EU wide discussion on this the European Commission in its road map to resource efficiency announced a Communication on land as a resource. This presentation will attempt to synthesize current discussion on the topic of 'land as a resource' and include examples of implemented innovative solutions for aging population, land recycling for urban developments and green spaces within the current EU policy context. Finally, some appreciation of the adopted UN Sustainable Development Goals regarding land and soil from the EU perspective will be given.

The efficacy of different models of smoke-free laws in reducing exposure to second-hand smoke: a multi-country comparison.

PubMed

Ward, Mark; Currie, Laura M; Kabir, Zubair; Clancy, Luke

2013-05-01

Exposure to second-hand tobacco smoke is a serious public health concern and while all EU Member States have enacted some form of regulation aimed at limiting exposure, the scope of these regulations vary widely and many countries have failed to enact comprehensive legislation creating smoke-free workplaces and indoor public places. To gauge the effectiveness of different smoke-free models we compared fine particles from second-hand smoke in hospitality venues before and after the implementation of smoking bans in France, Greece, Ireland, Italy, Portugal, Turkey, and Scotland. Data on PM2.5 fine particle concentration levels were recorded in 338 hospitality venues across these countries before and after the implementation of smoke-free legislation. Changes in mean PM2.5 concentrations during the period from pre- to post-legislation were then compared across countries. While a reduction in PM2.5 was observed in all countries, those who had enacted and enforced more fully comprehensive smoke-free legislation experienced the greatest reduction in second-hand tobacco smoke. Comprehensive smoke-free laws are more effective than partial laws in reducing exposure to second-hand tobacco smoke. Also, any law, regardless of scope must be actively enforced in order to have the desired impact. There is continued need for surveillance of smoke-free efforts in all countries. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

How Changing Human Lifestyles are Shaping Europe's Regional Seas

NASA Astrophysics Data System (ADS)

Mee, L. D.; Lowe, C. D.; Langmead, O.; McQuatters-Gollop, A.; Attrill, M.; Cooper, P.; Gilbert, A.; Knudsen, S.; Garnacho, E.

2007-05-01

European society is experiencing unprecedented changes triggered by expansion of the European Union, the fall of Communism, economic growth and the onset of globalisation. Europe's regional seas, the Baltic, Black Sea, Mediterranean and North-East Atlantic (including the North Sea), provide key goods and services to the human population but have suffered from severe degradation in past decades. Their integrity as coupled social and ecological systems depends on how humanity will anticipate potential problems and deal with its ecological footprint in the future. We report the outcome of an EU-funded 15-country, 28 institution project entitled European Lifestyles and Marine Ecosystems (ELME). Our studies were designed to inform new EU policy and legislation that incorporates Ecosystem-Based Management. ELME has modelled the key relationships between economic and social drivers (D), environmental pressures (P) and changes in the state of the environment (S) in Europe's regional seas. We examined four key issues in each sea: habitat change, eutrophication, chemical pollution and fisheries. We developed conceptual models for each regional sea and employed a novel stochastic modelling technique to examine the interrelationship between key components of the conceptual models. We used the models to examine 2-3 decade projections of current trends in D, P and S and how a number of alternative development scenarios might modify these trends. These simulations demonstrate the vulnerability of Europe's seas to human pressure. As affluence increases in countries acceding to the EU, so does the demand for marine goods and services. There are `winners' and `losers' amongst marine species; the winners are often species that are opportunistic invaders or those with low economic value. In the case of eutrophication, semi-enclosed seas such as the Baltic or Black Sea are already affected by the `legacy of the past'; nutrients that have accumulated in soils, ground waters and sediments and are gradually released to the water column. This situation is analogous to climate change `locked in' by current greenhouse gas concentrations that are products of past economic activities. For the Baltic Sea for example, only a radical reduction in both phosphorus and nitrogen loads to the sea would overcome eutrophication, and future management strategies must contemplate adaptation as well as mitigation. These strategies will also need to accommodate climate change, regime shifts and emergent issues such as `lifestyle' chemicals and the massive development of offshore renewable energy.

Sharing and reusing cardiovascular anatomical models over the Web: a step towards the implementation of the virtual physiological human project.

PubMed

Gianni, Daniele; McKeever, Steve; Yu, Tommy; Britten, Randall; Delingette, Hervé; Frangi, Alejandro; Hunter, Peter; Smith, Nicolas

2010-06-28

Sharing and reusing anatomical models over the Web offers a significant opportunity to progress the investigation of cardiovascular diseases. However, the current sharing methodology suffers from the limitations of static model delivery (i.e. embedding static links to the models within Web pages) and of a disaggregated view of the model metadata produced by publications and cardiac simulations in isolation. In the context of euHeart--a research project targeting the description and representation of cardiovascular models for disease diagnosis and treatment purposes--we aim to overcome the above limitations with the introduction of euHeartDB, a Web-enabled database for anatomical models of the heart. The database implements a dynamic sharing methodology by managing data access and by tracing all applications. In addition to this, euHeartDB establishes a knowledge link with the physiome model repository by linking geometries to CellML models embedded in the simulation of cardiac behaviour. Furthermore, euHeartDB uses the exFormat--a preliminary version of the interoperable FieldML data format--to effectively promote reuse of anatomical models, and currently incorporates Continuum Mechanics, Image Analysis, Signal Processing and System Identification Graphical User Interface (CMGUI), a rendering engine, to provide three-dimensional graphical views of the models populating the database. Currently, euHeartDB stores 11 cardiac geometries developed within the euHeart project consortium.

Physics of Efficiency Droop in GaN:Eu Light-Emitting Diodes.

PubMed

Fragkos, Ioannis E; Dierolf, Volkmar; Fujiwara, Yasufumi; Tansu, Nelson

2017-12-01

The internal quantum efficiency (IQE) of an electrically-driven GaN:Eu based device for red light emission is analyzed in the framework of a current injection efficiency model (CIE). The excitation path of the Eu +3 ion is decomposed in a multiple level system, which includes the carrier transport phenomena across the GaN/GaN:Eu/GaN active region of the device, and the interactions among traps, Eu +3 ions and the GaN host. The identification and analysis of the limiting factors of the IQE are accomplished through the CIE model. The CIE model provides a guidance for high IQE in the electrically-driven GaN:Eu based red light emitters.

Fuzzy risk explicit interval linear programming model for end-of-life vehicle recycling planning in the EU.

PubMed

Simic, Vladimir

2015-01-01

End-of-life vehicles (ELVs) are vehicles that have reached the end of their useful lives and are no longer registered or licensed for use. The ELV recycling problem has become very serious in the last decade and more and more efforts are made in order to reduce the impact of ELVs on the environment. This paper proposes the fuzzy risk explicit interval linear programming model for ELV recycling planning in the EU. It has advantages in reflecting uncertainties presented in terms of intervals in the ELV recycling systems and fuzziness in decision makers' preferences. The formulated model has been applied to a numerical study in which different decision maker types and several ELV types under two EU ELV Directive legislative cases were examined. This study is conducted in order to examine the influences of the decision maker type, the α-cut level, the EU ELV Directive and the ELV type on decisions about vehicle hulks procuring, storing unprocessed hulks, sorting generated material fractions, allocating sorted waste flows and allocating sorted metals. Decision maker type can influence quantity of vehicle hulks kept in storages. The EU ELV Directive and decision maker type have no influence on which vehicle hulk type is kept in the storage. Vehicle hulk type, the EU ELV Directive and decision maker type do not influence the creation of metal allocation plans, since each isolated metal has its regular destination. The valid EU ELV Directive eco-efficiency quotas can be reached even when advanced thermal treatment plants are excluded from the ELV recycling process. The introduction of the stringent eco-efficiency quotas will significantly reduce the quantities of land-filled waste fractions regardless of the type of decision makers who will manage vehicle recycling system. In order to reach these stringent quotas, significant quantities of sorted waste need to be processed in advanced thermal treatment plants. Proposed model can serve as the support for the European vehicle recycling managers in creating more successful ELV recycling plans. Copyright © 2014 Elsevier Ltd. All rights reserved.

An Assessment of EU 2020 Strategy: Too Far to Reach?

ERIC Educational Resources Information Center

Colak, Mehmet Selman; Ege, Aylin

2013-01-01

In 2010, EU adopted a new growth strategy which includes three growth priorities and five headline targets to be reached by 2020. The aim of this paper is to investigate the current performance of the EU member and candidate states in achieving these growth priorities and the overall strategy target by allocating the headline targets into the…

Determination of Ochratoxin A in Black and White Pepper, Nutmeg, Spice Mix, Cocoa, and Drinking Chocolate by High-Performance Liquid Chromatography Coupled with Fluorescence Detection: Collaborative Study.

PubMed

Cubero-Leon, Elena; Bouten, Katrien; Senyuva, Hamide; Stroka, Joerg

2017-09-01

A method validation study for the determination of ochratoxin A in black and white pepper (Piper spp.), nutmeg (Myristica fragrans), spice mix (blend of ginger, turmeric, pepper, nutmeg, and chili), cocoa powder, and drinking chocolate was conducted according to the International Harmonized Protocol of the International Union of Pure and Applied Chemistry. The method is based on the extraction of samples with aqueous methanol, followed by a cleanup of the extract with an immunoaffinity column. The determination is carried out by reversed-phase LC coupled with a fluorescence detector. The study involved 25 participants representing a cross-section of research, private, and official control laboratories from 12 European Union (EU) Member States, together with Turkey and Macedonia. Mean recoveries ranged from 71 to 85% for spices and from 85 to 88% for cocoa and drinking chocolate. The RSDr values ranged from 5.6 to 16.7% for spices and from 4.5 to 18.7% for cocoa and drinking chocolate. The RSDR values ranged from 9.5 to 22.6% for spices and from 13.7 to 30.7% for cocoa and drinking chocolate. The resulting Horwitz ratios ranged from 0.4 to 1 for spices and from 0.6 to 1.4 for cocoa and drinking chocolate according to the Horwitz function modified by Thompson. The method showed acceptable within-laboratory and between-laboratory precision for each matrix, and it conforms to requirements set by current EU legislation.

New developments in children's environmental health in Europe.

PubMed

Tamburlini, Giorgio

2006-09-01

Important developments have taken place in Europe regarding children's environmental health (CEH) over the last few years. In 1999 the Third Ministerial Conference on Environment and Health identified CEH as a priority area and started a process of scientific review and policy development that culminated at the Fourth Ministerial Conference held in Budapest in June 2004 with the adoption of the Children's Environment and Health Action Plan for Europe (CEHAPE). The rationale of the CEHAPE is based on a thorough review of the scientific evidence on CEH and on a study that quantified for the first time the burden of disease related to the main environmental exposures of children and adolescents in Europe. The Action Plan suggests actions and policies to achieve the four main priority goals: clean air, safe water, chemical and physical agents, and injuries. Over the same period, the European Commission (EC) has strengthened its focus on environment and health issues, has supported research on CEH, and has developed a proposal for a new EU regulatory framework for chemicals that has clear implications for children and for the reproductive period. The proposed new system, called REACH (Registration, Evaluation, and Authorization of Chemicals), currently under examination by the European Parliament, aims at reducing risks to human health and improvement of environmental quality through the better and earlier identification of the properties of chemical substances. The EC also adopted policies and action plans that are very relevant to children, such as the EU European Environment and Health Strategy, referred to as the SCALE initiative (Science, Children, Awareness, Legislation, Evaluation), and the 2004-2010 Environment and Health Action Plan.

Policy brief on the current status of certification of electronic Health Records in the US and Europe.

PubMed

De Moor, Georges; O'Brien, John; Fridsma, Doug; Bean, Carol; Devlies, Jos; Cusack, Caitlin M; Bloomrosen, Meryl; Lorenzi, Nancy; Coorevits, Pascal

2011-01-01

If Electronic Health Record systems are to provide an effective contribution to healthcare, a set of benchmarks need to be set to ensure quality control and interoperability of systems. This paper outlines the prevailing status of EHR certification in the US and the EU, compares and contrasts established schemes and poses opportunities for convergence of activity in the domain designed to advance certification endeavours generally. Several EU Member States have in the past proceeded with EHR systems quality labeling and/or certification, but these differ in scope, in legal framework under which they operate, in policies (legislation and financial incentives), in organization, and perhaps most importantly in the quality criteria used for benchmarking. Harmonization, therefore, became a must. Now, through EuroRec (with approaches ranging from self-assessment to third party certification depending on the level of confidence needed) and its Seals, the possibility to achieve this for EHR systems has started in the whole of Europe. The US HITECH Act also attempts to create incentives for all hospitals and eligible providers to adopt and use electronic information. A centerpiece of the Act is to put in place strong financial incentives to adopt and meaningfully use EHRs. The HHS/EHR Certification Programme makes use of ISO/IEC 170XX standards for accreditation, testing and certification. The approved test method addresses the functional and the interoperability requirements defined in the Final Rule criteria and standards. To date six Authorized Testing and Certification Bodies (ATCBs) are testing and certifying products in the US.

Evaluating the impact of Brexit on the pharmaceutical industry.

PubMed

Kazzazi, Fawz; Pollard, Cleo; Tern, Paul; Ayuso-Garcia, Alejandro; Gillespie, Jack; Thomsen, Inesa

2017-01-01

The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry.

Challenges and Opportunities for Biophotonic Devices in the Liquid State and the Solid State

DTIC Science & Technology

2006-07-01

of the NPB:Eu device and a baseline device (without the NPB layer and emitting from the Alq3 layer) as a function of current density. The luminance...of the NPB:Eu device is clearly superior, with a maximum of 590 cd/m2 at 375 mA/cm2, whereas the Alq3 OLED peaks at only 45 cd/m2 at 30 mA/cm2...Luminance versus current density for Eu-doped BioLED and for baseline Alq3 device. 1-4244-0078-3/06/$20.00 (c) 2006 IEEE B. Electrofluidic

Copernicus Earth observation programme

NASA Astrophysics Data System (ADS)

Žlebir, Silvo

European Earth observation program Copernicus is an EU-wide programme that integrates satellite data, in-situ data and modeling to provide user-focused information services to support policymakers, researchers, businesses and citizens. Land monitoring service and Emergency service are fully operational already, Atmosphere monitoring service and Marine environment monitoring service are preoperational and will become fully operational in the following year, while Climate change service and Security service are in an earlier development phase. New series of a number of dedicated satellite missions will be launched in the following years, operated by the European Space Agency and EUMETSAT, starting with Sentinel 1A satellite early this year. Ground based, air-borne and sea-borne in-situ data are provided by different international networks and organizations, EU member states networks etc. European Union is devoting a particular attention to secure a sustainable long-term operational provision of the services. Copernicus is also stated as a European Union’s most important contribution to Global Earth Observation System of Systems (GEOSS). The status and the recent development of the Copernicus programme will be presented, together with its future perspective. As Copernicus services have already demonstrated their usability and effectiveness, some interesting cases of their deployment will be presented. Copernicus free and open data policy, supported by a recently adopted EU legislative act, will also be presented.

European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health

PubMed Central

Bates, C; Fagerstrom, K; Jarvis, M; Kunze, M; McNeill, A; Ramstrom, L

2003-01-01

Rationale: This statement is an updated version of one released by the same authors in February 2003. The statement was produced to follow up the Royal College of Physicians (RCP) Tobacco Advisory Group report "Protecting smokers, saving lives: the case for a tobacco and nicotine regulatory authority",1 which argued for an evidence based regulatory approach to smokeless tobacco and harm reduction and posed a series of questions that regulators must address in relation to smokeless tobacco. The purpose of this statement is to provide arguments of fact and principle to follow the RCP's report and to outline the public health case for changing existing European Union (EU) regulation in this area. A review of regulation in relation to harm reduction and regulation of tobacco products other than cigarettes is required in Article 11 of EU directive 2001/37/EC,2 and this is a contribution towards forming a consensus in the European public health community about what policy the EU should adopt in the light of this review, or following ongoing legal action that may potentially strike out the existing regulation altogether. Public health case: We believe that the partial ban applied to some forms of smokeless tobacco in the EU should be replaced by regulation of the toxicity of all smokeless tobacco. We hold this view for public health reasons: smokeless tobacco is substantially less harmful than smoking and evidence from Sweden suggests it is used as a substitute for smoking and for smoking cessation. To the extent there is a "gateway" it appears not to lead to smoking, but away from it and is an important reason why Sweden has the lowest rates of tobacco related disease in Europe. We think it is wrong to deny other Europeans this option for risk reduction and that the current ban violates rights of smokers to control their own risks. For smokers that are addicted to nicotine and cannot or will not stop, it is important that they can take advantage of much less hazardous forms of nicotine and tobacco—the alternative being to "quit or die"... and many die. While nicotine replacement therapies (NRT) may have a role in harm reduction, tobacco based harm reduction options may reach more smokers and in a different, market based, way. Chewing tobacco is not banned or regulated in the EU but is often highly toxic, and our proposal could remove more products from the market than it permitted. Regulatory options: We believe that the EU policy on smokeless tobacco should adapt to new scientific knowledge and that the European Commission should bring forward proposals to amend or replace Article 8 of directive 2001/37/EC with a new regulatory framework. Canada has developed testing regimens for tobacco constituents and these could be readily adapted to the European situation. A review of EU policy in this area is required no later than December 2004, and we believe the Commission should expedite the part of its review that deals with harm reduction and regulation of tobacco products other than cigarettes so as to reconsider its policy on smokeless tobacco. We held this view before Swedish Match brought its legal proceedings to challenge EU legislation and we will continue to hold these views if its action fails. PMID:14660767

Modelling forest carbon stock changes as affected by harvest and natural disturbances. II. EU-level analysis.

PubMed

Pilli, Roberto; Grassi, Giacomo; Kurz, Werner A; Moris, Jose V; Viñas, Raúl Abad

2016-12-01

Forests and the forest sector may play an important role in mitigating climate change. The Paris Agreement and the recent legislative proposal to include the land use sector in the EU 2030 climate targets reflect this expectation. However, greater confidence on estimates from national greenhouse gas inventories (GHGI) and more comprehensive analyses of mitigation options are needed to seize this mitigation potential. The aim of this paper is to provide a tool at EU level for verifying the EU GHGI and for simulating specific policy and forest management scenarios. Therefore, the Carbon Budget Model (CBM) was applied for an integrated assessment of the EU forest carbon (C) balance from 2000 to 2012, including: (i) estimates of the C stock and net CO 2 emissions for forest management (FM), afforestation/reforestation (AR) and deforestation (D), covering carbon in both the forest and the harvest wood product (HWP) pools; (ii) an overall analysis of the C dynamics associated with harvest and natural disturbances (mainly storms and fires); (iii) a comparison of our estimates with the data reported in the EU GHGI. Overall, the average annual FM sink (-365 Mt CO 2 year -1 ) estimated by the CBM in the period 2000-2012 corresponds to about 7 % of total GHG emissions at the EU level for the same period (excluding land use, land-use change and forestry). The HWP pool sink (-44 Mt CO 2 year -1 ) contributes an additional 1 %. Emissions from D (about 33 Mt CO 2 year -1 ) are more than compensated by the sink in AR (about 43 Mt CO 2 year -1 over the period). For FM, the estimates from the CBM were about 8 % lower than the EU GHGI, a value well within the typical uncertainty range of the EU forest sink estimates. For AR and D the match with the EU GHGI was nearly perfect (difference <±2 % in the period 2008-2012). Our analysis on harvest and natural disturbances shows that: (i) the impact of harvest is much greater than natural disturbances but, because of salvage logging (often very relevant), the impact of natural disturbances is often not easily distinguishable from the impact of harvest, and (ii) the impact of storms on the biomass C stock is 5-10 times greater than fires, but while storms cause only indirect emissions (i.e., a transfer of C from living biomass to dead organic matter), fires cause both direct and indirect emissions. This study presents the application of a consistent methodological approach, based on an inventory-based model, adapted to the forest management conditions of EU countries. The approach captures, with satisfactory detail, the C sink reported in the EU GHGI and the country-specific variability due to harvest, natural disturbances and land-use changes. To our knowledge, this is the most comprehensive study of its kind at EU level, i.e., including all the forest pools, HWP and natural disturbances, and a comparison with the EU GHGI. The results provide the basis for possible future policy-relevant applications of this model, e.g., as a tool to support GHGIs (e.g., on accounting for natural disturbances) and to verify the EU GHGI, and for the simulation of specific scenarios at EU level.

Current Status of Legislative Proposals on Greenhouse Gas Emissions and Alternative Energy in the U.S. Congress

NASA Astrophysics Data System (ADS)

Richardson, L. J.

2007-12-01

The 110th Congress is now beginning to grapple with the issue of human-induced climate change and what, if anything, to do about it. A number of bills are currently being considered that would limit greenhouse gas emissions using various policy mechanisms and over various time frames. With a commitment by the current Congressional leadership to pass legislation addressing global warming, and significant hurdles remaining, it promises to be an eventful fall session. I will review the current status of these legislative proposals and their prospects of becoming law.

Research challenges in municipal solid waste logistics management.

PubMed

Bing, Xiaoyun; Bloemhof, Jacqueline M; Ramos, Tania Rodrigues Pereira; Barbosa-Povoa, Ana Paula; Wong, Chee Yew; van der Vorst, Jack G A J

2016-02-01

During the last two decades, EU legislation has put increasing pressure on member countries to achieve specified recycling targets for municipal household waste. These targets can be obtained in various ways choosing collection methods, separation methods, decentral or central logistic systems, etc. This paper compares municipal solid waste (MSW) management practices in various EU countries to identify the characteristics and key issues from a waste management and reverse logistics point of view. Further, we investigate literature on modelling municipal solid waste logistics in general. Comparing issues addressed in literature with the identified issues in practice result in a research agenda for modelling municipal solid waste logistics in Europe. We conclude that waste recycling is a multi-disciplinary problem that needs to be considered at different decision levels simultaneously. A holistic view and taking into account the characteristics of different waste types are necessary when modelling a reverse supply chain for MSW recycling. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Hope for patients with rare diseases--"orphan" drugs].

PubMed

Kuzelová, M; Kubácková, K; Palágyi, M; Smíd, M

2006-01-01

Rare diseases are defined as those affected less than five in every 10 000 person in European Union. The purpose of this paper is to present activities, which make possible to stimulate research development and marketing of appropriate medicine for tretment of rare disease, named "Orphan" medicinal products. EU "Orphan" medicinal products legislation which entered into force in April 2000 is described. Definition of "Orphan" medicinal products as well as the procedure of designation and placing the products into the Community register is presented. Those incentives to industry are described, which are already five years very well implemented oh the European level mostly on the pre-authorisation phase of "Orphan" medicinal products development, but also in the registration process as well as the post-authorisation phase. Finaly, the first twenty "Orphan" medicinal products, which have been given positive opinion in the Community for the grant of a marketing authorisation till April 2005 are mentioned in this work. The real availability of "Orphan" medicinal products in the particular EU member states is analysed.

A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.

PubMed

Tanti, Amy; Micallef, Benjamin; Serracino-Inglott, Anthony; Borg, John-Joseph

2017-01-01

Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems. Expert opinion: Within a ten year period, 3 EU directives on pharmacovigilance were implemented by our agency. Despite limitations to resources, based on a prioritised implementation, the legislation provisions are now fully operational with a good level of sustainability. Lessons learnt from this process are discussed in this review. The coming years will involve strengthening and consolidation of existing processes.

[100 years of drinking water regulation. Retrospective review, current situation and prospects].

PubMed

Rakhmanin, Yu A; Krasovsky, G N; Egorova, N A; Mikhailova, R I

2014-01-01

There is considered the history of the development of legislative requirements to the regulation of the quality of drinking water in different countries and international organizations during the period from 1912 to the present time. In terms of comparative analysis there is analyzed the current state of regulatory frameworks of the Russian Federation, WHO, EU, Finland, the UK, Singapore, Australia, Japan, China, Nigeria, the United States and Canada in the field of providing favorable conditions of population drinking water use. There has been noted the significant progress in standardization of the content of the biogenic elements and chemical pollution of drinking water in the absence of uniform requirements to the composition and properties of drinking water globally, that is bound to the need to take into account the national peculiarities of drinking water supply within the separate countries. As promising directions for improving regulation of drinking water quality there are noted: the development of new standards for prioritized water pollution, periodic review ofstandards after appearance of the new scientific data on the biological action of substances, the use of the concept of risk, the harmonization of the normative values and the assessment of the possibility of introduction into the practice the one more criterion of profitableness of population water use--the bioenergetic state of the water.

Detecting and assessing Saharan dust contribution to PM10 loads: A pilot study within the EU-Life+10 project DIAPASON

NASA Astrophysics Data System (ADS)

Gobbi, Gian Paolo; Barnaba, Francesca; Bolignano, Andrea; Costabile, Francesca; Di Liberto, Luca; Dionisi, Davide; Drewnick, Frank; Lucarelli, Franco; Manigrasso, Maurizio; Nava, Silvia; Sauvage, Laurent; Sozzi, Roberto; Struckmeier, Caroline; Wille, Holger

2015-04-01

The EC LIFE+2010 DIAPASON Project (Desert dust Impact on Air quality through model-Predictions and Advanced Sensors ObservatioNs, www.diapason-life.eu) intends to contribute new methodologies to assess the role of aerosol advections of Saharan dust to the local PM loads recorded in Europe. To this goal, automated Polarization Lidar-Ceilometers (PLCs) were prototyped within DIAPASON to certify the presence of Saharan dust plumes and support evaluating their mass loadings in the lowermost atmosphere. The whole process also involves operational dust forecasts, as well as satellite and in-situ observations. Demonstration of the Project is implemented in the pilot region of Rome (Central Italy) where three networked DIAPASON PLCs started, in October 2013 a year-round, 24h/day monitoring of the altitude-resolved aerosol backscatter and depolarization profiles. Two intensive observational periods (IOPs) involving chemical analysis and detailed physical characterization of aerosol samples have also been carried out in this year-long campaign, namely in Fall 2013 and Spring 2014. These allowed for an extensive interpretation of the PLC observations, highlighting important synergies between the PLC and the in situ data. The presentation will address capabilities of the employed PLCs, observations agreement with model forecasts of dust advections, retrievals of aerosol properties and methodologies developed to detect Saharan advections and to evaluate the relevant mass contribution to PM10. This latter task is intended to provide suggestions on possible improvements to the current EC Guidelines (2011) on this matter. In fact, specific Guidelines are delivered by the European Commission to provide the Member States a common method to asses the Saharan dust contribution to the currently legislated PM-related Air Quality metrics. The DIAPASON experience shows that improvements can be proposed to make the current EC Methodology more robust and flexible. The methodology DIAPASON recommends has been designed and validated taking advantage of the PLC observations and highlights the benefits of the operational use of such systems in routine Air Quality applications. Concurrently, PLC activities are contributing to the COST Action "TOPROF", an European effort aiming at the setup and operational use of Lidar-Ceilometers networks for meteorological and safety purposes.

Used battery collection in central Mexico: metal content, legislative/management situation and statistical analysis.

PubMed

Guevara-García, José Antonio; Montiel-Corona, Virginia

2012-03-01

A statistical analysis of a used battery collection campaign in the state of Tlaxcala, Mexico, is presented. This included a study of the metal composition of spent batteries from formal and informal markets, and a critical discussion about the management of spent batteries in Mexico with respect to legislation. A six-month collection campaign was statistically analyzed: 77% of the battery types were "AA" and 30% of the batteries were from the informal market. A substantial percentage (36%) of batteries had residual voltage in the range 1.2-1.4 V, and 70% had more than 1.0 V; this may reflect underutilization. Metal content analysis and recovery experiments were performed with the five formal and four more frequent informal trademarks. The analysis of Hg, Cd and Pb showed there is no significant difference in content between formal and informal commercialized batteries. All of the analyzed trademarks were under the permissible limit levels of the proposed Mexican Official Norm (NOM) NMX-AA-104-SCFI-2006 and would be classified as not dangerous residues (can be thrown to the domestic rubbish); however, compared with the EU directive 2006/66/EC, 8 out of 9 of the selected battery trademarks would be rejected, since the Mexican Norm content limit is 20, 7.5 and 5 fold higher in Hg, Cd and Pb, respectively, than the EU directive. These results outline the necessity for better regulatory criteria in the proposed Mexican NOM in order to minimize the impact on human health and the environment of this type of residues. Copyright © 2010 Elsevier Ltd. All rights reserved.

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

PubMed

Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

2017-04-01

To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

Comparative studies of oil product regulation in polluted soil for several industrialized countries

NASA Astrophysics Data System (ADS)

Paccassoni, F.; Kalnina, D.; Piga, L.

2017-10-01

Oil contaminated sites are the consequence of a long period of industrialization. Oil is a complex mixture including aliphatic and aromatic hydrocarbons, which are known to have negative effects on human health and the environment. Dividing oil products in groups (fractions) of petroleum hydrocarbons that act alike in soil and water, one can better know what happens to them. Being able to understand the behaviour of oil products in soil, it will allow to implement prevention and remediation actions. Interventions on contaminated sites are bound to comply with regulatory limits that each country has set in their own environmental legislation. The different concentration thresholds of oil products in soil for several EU countries and Canada has led to compare: limit values, analytical method, soil characteristics and/or land use. This will allow to evaluate what could be the best regulation approach, assessing if it is better to consider soil matrix in the site or the specific land use or both of them. It will also assess what is the best analytical methodology to be adopted to achieve the pollutant concentrations in the soil in order to have comparable results among different countries, such as: Baltic countries (Latvia, Estonia, Lithuania), Nordic countries (Finland, Sweden, Norway, Denmark), Western countries (Italy and The Netherlands) and Canada, like gaschromatography in the range from C10 - C50. The study presents an overview of environmental regulatory system of several EU countries and Canada and the correlation between different parameters about oil products indicated in each environmental legislation.

Spurious claims for health-care products: an experimental approach to evaluating current UK legislation and its implementation.

PubMed

Rose, Leslie B; Posadzki, Paul; Ernst, Edzard

2012-01-01

The lay media, and especially the Internet, contain many misleading claims for health products which have previously been inadequately regulated by consumer law. This was an experimental interventional survey within a consumer health-care setting. Three health products were chosen on the basis of being widely available on the UK market and having no available evidence of effectiveness. Twelve volunteers submitted 39 complaints to Consumer Direct (UK portal for the regulator Trading Standards) regarding false health claims, and 36 complaints were followed up for a maximum of 4.8 months. The mean time from submission of complaints to Consumer Direct to acknowledgement by the relevant Trading Standards office was 13 days. There were no responses from Trading Standards for 22% of complaints. At the end of the study one supplier had amended their website following Trading Standards advice, but did not stop all health claims. Another stopped advertising their product on the Internet and the third continued the health claims unchanged. EU directive 2005/29/EC is largely ineffective in preventing misleading health claims for consumer products in the UK.

Impact of cigarette price differences across the entire European Union on cross-border purchase of tobacco products among adult cigarette smokers.

PubMed

Agaku, Israel T; Blecher, Evan; Filippidis, Filippos T; Omaduvie, Uyoyo T; Vozikis, Athanassios; Vardavas, Constantine I

2016-05-01

We investigated the impact of cigarette price differences across the European Union (EU) on cross-border tobacco purchasing because of cheaper price among current cigarette smokers. Individual-level tobacco-related data (including cross-border tobacco purchasing behavior) were from the Special Eurobarometer 385 (V.77.1), a cross-sectional survey of persons aged ≥15 years from 27 EU Member States during 2012. Country-specific weighted average prices (WAP) per 1000 cigarettes (as of 1 July 2012) were obtained from the European Commission, and divided by 50 to yield WAP per cigarette pack. The dispersion in EU cigarette prices was measured with the coefficient of variation. Multivariate logistic regression was applied to measure the relationship between EU-wide cigarette price differential and cross-border tobacco purchasing because of cheaper price among current cigarette smokers (n=6896). The coefficient of variation for cigarette WAP within the EU was 0.39 (mean price=€3.99/pack). Of all current cigarette smokers in the EU, 26.2% (27.5 million persons) engaged in a cross-border tobacco purchase within the past 12 months, of which 56.3% did so because of cheaper price in another country. EU-wide cigarette price differential was significantly associated with making a cross-border tobacco purchase because of cheaper price (adjusted OR=1.34; 95% CI 1.22 to 1.47). Reducing differences in cigarette tax and price within the EU, coupled with a stricter limitation on the quantity of cigarettes that it is possible to carry from one Member State to another, may help reduce cross-border tax avoidance strategies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The revision of the 2014 European tobacco products directive: an analysis of the tobacco industry's attempts to ‘break the health silo’

PubMed Central

Peeters, Silvy; Costa, Hélia; Stuckler, David; McKee, Martin; Gilmore, Anna B

2016-01-01

Background The 2014 European Union (EU) Tobacco Products Directive (TPD) was negotiated in a changed policy context, following adoption of the EU's ‘Smart Regulation’ agenda, which transnational tobacco companies (TTCs) anticipated would increase their influence on health policy, and the WHO Framework Convention on Tobacco Control (FCTC), which sought to reduce it. This study aims to explore the scale and nature of the TTCs' lobby against the EU TPD and evaluate how these developments have affected their ability to exert influence. Methods Analysis of 581 documents obtained through freedom of information requests, 28 leaked Philip Morris International (PMI) documents, 17 TTC documents from the Legacy Library, web content via Google alerts and searches of the EU institutions' websites, plus four stakeholder interviews. Results The lobby was massive. PMI alone employed over 160 lobbyists. Strategies mainly used third parties. Efforts to 'Push' (amend) or 'Delay' the proposal and block 'extreme policy options' were partially successful, with plain packaging and point of sales display ban removed during the 3-year delay in the Commission. The Smart Regulation mechanism contributed to changes and delays, facilitating meetings between TTC representatives (including ex-Commission employees) and senior Commission staff. Contrary to Article 5.3, these meetings were not disclosed. Conclusions During the legislative process, Article 5.3 was not consistently applied by non-health Directorates of the European Commission, while the tools of the Smart Regulation appear to have facilitated TTC access to, and influence on, the 2014 TPD. The use of third parties undermines Article 5.3. PMID:25713313

The EU legislation on “GMOs” between nonsense and protectionism: An ongoing Schumpeterian chain of public choices

PubMed Central

Tagliabue, Giovanni

2017-01-01

ABSTRACT The EU regulation of agricultural biotechnology is botched and convoluted: the pseudo-concept of “Genetically Modified Organisms” has no coherent semantic or scientific content. The reasons of the paradox by which the cultivation of “GMOs” is substantially banned in Europe, while enormous quantities of recombinant-DNA cereals and legumes are imported to be used as feedstuff, are explained. The Directive 2015/412, giving Member states the choice to refuse the cultivation of genetically engineered crops at a national or local level, paves the way for a mosaic-like, Harlequinesque form of protectionism: nothing resembling a well-regulated free market. In the meantime, importation of “GMO” feed goes on at full speed all over Europe. A proposal by the Commission to adjust the rules on importation according to those for cultivation has been rejected by the Parliament.This dynamics may be seen as an ongoing “Schumpeterian” chain of public choices: the calculus of consent drives politicians more than a science-based approach to law-making.  The EU should restart from scratch with the right concept, i.e. the careful examination of the pros and cons, the costs and benefits of each new agricultural product (“GMO” or otherwise), freely cultivated and/or imported, assessed case by case, at last acknowledging that the biotech processes used to create new varieties are of no practical or legal relevance. In doing so, the EU would pursue its stated “better regulation” approach, cancelling any sectoral and sectarian regulation. PMID:28001470

Finding Your Way in the Legislation Maze: How To Pass Legislation in Your State.

ERIC Educational Resources Information Center

Gross, Steve

1997-01-01

Offers tips for developing and passing legislation that would protect animals. Recommends being an authority on the issue, researching current laws, recognizing support groups and lobbyists, and knowing key legislative players. Contains a description of laws passed in the state of Illinois. (PVD)

Characterisation of extra virgin olive oils from Galician autochthonous varieties and their co-crushings with Arbequina and Picual cv.

PubMed

Reboredo-Rodríguez, P; González-Barreiro, C; Cancho-Grande, B; Fregapane, G; Salvador, M D; Simal-Gándara, J

2015-06-01

The current trend of the olive oil market is the production of high quality extra from traditional minor olive varieties with peculiar and differentiated characteristics (especially with respect to the aromatic and phenolic composition). In this way, the interest of Galician oil producers (NW Spain) in recovering old autochthonous Local olive fruits has increased substantially in recent years. In order to investigate the potential of the Local olives by either producing high quality monovarietal oils or mixing with the most widespread olives in Galicia (Arbequina and Picual cv.), quality indices, and fatty acid composition as well as volatile and phenolic profiles were determined and compared. All EVOOs studied in this work can be considered as "extra virgin olive oil" due to quality indices fell within the ranges established in legislation. Picual and Local olive oils as well as those resulting from their co-crushing reach values which are required by EU legislation to add the specific health claim on the oil label. Co-crushing Picual:Local (80:20) provided a significant enhancement of grass and apple nuances and a decrease of banana notes with respect to Picual oils. The co-crushing process improved sensory and health properties of Picual extra virgin olive oils. The effect of co-crushing on phenolics, ester volatiles and banana nuances cannot be easily modulated, contrary to quality indices and fatty acid composition, both changing linearly in strict correlation with the fruit mass ratio. Copyright © 2014 Elsevier Ltd. All rights reserved.

History and current status of strontium iodide scintillators

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cherepy, Nerine J.; Beck, Patrick R.; Payne, Stephen A.

Eu-doped strontium iodide single crystal growth has reached maturity and prototype SrI 2(Eu)-based gamma ray spectrometers provide detection performance advantages over standard detectors. SrI 2(Eu) offers a high, proportional light yield of >80,000 photons/MeV. Energy resolution of <3% at 662 keV with 1.5” x 1.5” SrI2(Eu) crystals is routinely achieved, by employing either a small taper at the top of the crystal or a digital readout technique. These methods overcome light-trapping, in which scintillation light is re-absorbed and re-emitted in Eu 2+-doped crystals. As a result, its excellent energy resolution, lack of intrinsic radioactivity or toxicity, and commercial availability makemore » SrI 2(Eu) the ideal scintillator for use in handheld radioisotope identification devices. A 6-lb SrI 2(Eu) radioisotope identifier is described.« less

History and current status of strontium iodide scintillators

DOE PAGES

Cherepy, Nerine J.; Beck, Patrick R.; Payne, Stephen A.; ...

2017-09-15

Eu-doped strontium iodide single crystal growth has reached maturity and prototype SrI 2(Eu)-based gamma ray spectrometers provide detection performance advantages over standard detectors. SrI 2(Eu) offers a high, proportional light yield of >80,000 photons/MeV. Energy resolution of <3% at 662 keV with 1.5” x 1.5” SrI2(Eu) crystals is routinely achieved, by employing either a small taper at the top of the crystal or a digital readout technique. These methods overcome light-trapping, in which scintillation light is re-absorbed and re-emitted in Eu 2+-doped crystals. As a result, its excellent energy resolution, lack of intrinsic radioactivity or toxicity, and commercial availability makemore » SrI 2(Eu) the ideal scintillator for use in handheld radioisotope identification devices. A 6-lb SrI 2(Eu) radioisotope identifier is described.« less

Kentucky pharmacists' opinions of the potential reclassification of pseudoephedrine as a legend drug

PubMed Central

Monson, Kathleen E.; Freeman, Patricia R.; Goodin, Amie J.; Talbert, Jeffery; Blumenschein, Karen

2015-01-01

Objectives To collect and analyze Kentucky pharmacists' opinions of the effectiveness of current methamphetamine precursor controls, to analyze proposed legislation to make pseudoephedrine (PSE) a legend drug, and to analyze the potential impact of such legislation on pharmacy practice and patients. Design Descriptive, nonexperimental survey study. Setting Kentucky; June through October 2012. Participants 431 Kentucky community pharmacists. Intervention Mailed survey. Main outcome measures Perceived efficacy of current methamphetamine precursor controls, anticipated impact on individual pharmacy practices and patients of proposed legislation to make PSE available by prescription only, and current opinions about the proposed legislation. Results Analysis of 431 community pharmacists showed that approximately 77% believed proposed legislation to make PSE available by prescription only would be effective in reducing methamphetamine abuse and methamphetamine-related laboratory incidents, with 56.2% indicating support for the proposed legislation. Pharmacists practicing in chain pharmacies were 2.9 times more likely to support the legislation than pharmacists practicing in independent pharmacies. Additional factors influencing pharmacist support included Kentucky region of practice, anticipated impact on time spent on PSE activities, pharmacy profit, methamphetamine abuse, and methamphetamine-related laboratory incidents. Pharmacists practicing in regions of Kentucky associated with higher methamphetamine abuse appear to more strongly support the proposed legislation. Conclusion Pharmacists are at the frontline of PSE distribution. Gaining a better understanding of issues surrounding the distribution of PSE will enhance the likelihood that future legislation may be crafted to reduce methamphetamine production, laboratory incidents, and abuse while minimizing inconvenience and cost. PMID:25063261

Kentucky pharmacists' opinions of the potential reclassification of pseudoephedrine as a legend drug.

PubMed

Monson, Kathleen E; Freeman, Patricia R; Goodin, Amie J; Talbert, Jeffery; Blumenschein, Karen

2014-01-01

To collect and analyze Kentucky pharmacists' opinions of the effectiveness of current methamphetamine precursor controls, to analyze proposed legislation to make pseudoephedrine (PSE) a legend drug, and to analyze the potential impact of such legislation on pharmacy practice and patients. Descriptive, nonexperimental survey study. Kentucky; June through October 2012. 431 Kentucky community pharmacists. Mailed survey. Perceived efficacy of current methamphetamine precursor controls, anticipated impact on individual pharmacy practices and patients of proposed legislation to make PSE available by prescription only, and current opinions about the proposed legislation. Analysis of 431 community pharmacists showed that approximately 77% believed proposed legislation to make PSE available by prescription only would be effective in reducing methamphetamine abuse and methamphetamine-related laboratory incidents, with 56.2% indicating support for the proposed legislation. Pharmacists practicing in chain pharmacies were 2.9 times more likely to support the legislation than pharmacists practicing in independent pharmacies. Additional factors influencing pharmacist support included Kentucky region of practice, anticipated impact on time spent on PSE activities, pharmacy profit, methamphetamine abuse, and methamphetamine-related laboratory incidents. Pharmacists practicing in regions of Kentucky associated with higher methamphetamine abuse appear to more strongly support the proposed legislation. Pharmacists are at the frontline of PSE distribution. Gaining a better understanding of issues surrounding the distribution of PSE will enhance the likelihood that future legislation may be crafted to reduce methamphetamine production, laboratory incidents, and abuse while minimizing inconvenience and cost.

Comparison of legislation, regulations and national health strategies for palliative care in seven European countries (Results from the Europall Research Group): a descriptive study.

PubMed

Van Beek, Karen; Woitha, Kathrin; Ahmed, Nisar; Menten, Johan; Jaspers, Birgit; Engels, Yvonne; Ahmedzai, Sam H; Vissers, Kris; Hasselaar, Jeroen

2013-07-17

According to EU policy, anyone in need of palliative care should be able to have access to it. It is therefore important to investigate which palliative care topics are subject to legislation and regulations in Europe and how these are implemented in (national) health care plans. This paper aims to deliver a structured overview of the legislation, existing regulations and the different health care policies regarding palliative care in seven European countries. In 2008 an inventory of the organisation of palliative care was developed by the researchers of the Europall project. Included were two open questions about legislation, regulations, and health policy in palliative care. This questionnaire was completed using palliative care experts selected from Belgium, England, France, Germany, the Netherlands, Poland and Spain. Additionally, (grey) literature on palliative care health policy and regulations from the participating countries was collected to complete the inventory. Comparative analysis of country specific information was performed afterwards. In all countries palliative care regulations and policies existed (either in laws, royal decrees, or national policies). An explicit right to palliative care was mentioned in the Belgium, French and German law. In addition, access to palliative care was mentioned by all countries, varying from explicit regulations to policy intentions in national plans. Also, all countries had a national policy on palliative care, although sometimes mainly related to national cancer plans. Differences existed in policy regarding palliative care leave, advance directives, national funding, palliative care training, research, opioids and the role of volunteers. Although all included European countries have policies on palliative care, countries largely differ in the presence of legislation and regulations on palliative care as well as the included topics. European healthcare policy recommendations should support palliative care access across Europe.

Current Legislation on Admission of Mentally Ill Patients in China

PubMed Central

Shao, Yang; Xie, Bin; Good, Mary-Jo DelVecchio; Good, Byron J.

2009-01-01

Objective To date, there is no systematic analysis of mental health laws and their implementation across the People’s Republic of China. This article aims to describe and analyze current legal frameworks for voluntary and involuntary admissions of mentally ill patients in the five cities of China that currently have municipal mental health regulations. Methods Information on the legislation and practice of involuntary admission in the five cities was gathered and assessed using the “WHO Checklist on Mental Health Legislation.” The checklist was completed for each city by a group of psychiatrists trained in mental health legislation. Results Although the mental health regulations in these five cities cover the basic principles needed to meet international standards of mental health legislation, some defects in the legislation remain. In particular, these regulations lack detail in specifying procedures for dealing with admission and treatment and lack oversight and review mechanisms and procedures for appeal of involuntary admission and treatment. Conclusions A more comprehensive and enforceable national mental health act is needed in order to ensure the rights of persons suffering mental illness in terms of admission and treatment procedures. In addition, more research is needed to understand how the current municipal regulations of mental health services in these cities are implemented in routine practice. PMID:19913300

NOx, NH3, N2O and PN real driving emissions from a Euro VI heavy-duty vehicle. Impact of regulatory on-road test conditions on emissions.

PubMed

Mendoza-Villafuerte, Pablo; Suarez-Bertoa, Ricardo; Giechaskiel, Barouch; Riccobono, Francesco; Bulgheroni, Claudia; Astorga, Covadonga; Perujo, Adolfo

2017-12-31

Euro VI emission standards for heavy-duty vehicles (HDVs) introduced for the first time limits for solid particle number (PN) and NH 3 emissions. EU regulation also includes a Portable Emissions Measurement System (PEMS) based test at type approval, followed by in-service conformity (ISC) testing. A comprehensive study on the real-time on-road emissions of NO x , NH 3 , N 2 O and PN from a Euro VI HDV equipped with a Diesel Oxidation Catalyst (DOC), a Diesel Particle Filter (DPF), a Selective Catalytic Reduction (SCR) system and an Ammonia Oxidation Catalyst (AMOX) is presented. Our analyses revealed that up to 85% of the NO x emissions measured during the tests performed are not taken into consideration if the boundary conditions for data exclusion set in the current legislation are applied. Moreover, it was found that the highest NO x emissions were measured during urban operation. Analyses show that a large fraction urban of operation is not considered when 20% power threshold as boundary condition is applied. They also show that cold start emissions account for a large fraction of the total NO x emitted. Low emissions of PN (2.8×10 10 to 6.5×10 10 #/kWh) and NH 3 (1.0 to 2.2ppm) were obtained during the on-road tests, suggesting effectiveness of the vehicle's after-treatment (DPF and AMOX). Finally, a comparison between speed-based (as currently defined by Euro VI legislation) and land-use-based (using Geographic Information System (GIS)) calculation of shares of operation was performed. Results suggest that using GIS to categorize the shares of operation could result in different interpretations depending on the criteria adopted for their definition. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

EU's new pharmacovigilance legislation: considerations for biosimilars.

PubMed

Calvo, Begoña; Zuñiga, Leyre

2014-01-01

Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment.

Politicization and institutional unclarity: the case of the Portuguese food agency.

PubMed

Domingues, Mafalda

2006-09-01

Recent changes in the institutional framework of food safety in Portugal have been initiated by BSE scandals and by EU legislative impact. Portuguese consumers have only recently moved from a poverty-related fear of food scarcity to modern fears of safety-related problems with food. Food safety is now highly politicized in Portugal, and the organization of food safety policies has been the topic of several parliamentary debates and of governmental reform. The chapter describes the political conflicts generated by the planned establishment of a new Food Agency-controversies which have so far hindered institutional change.

Looking for Skeletons in the Data Centre `Cupboard': How Repository Certification Can Help

NASA Astrophysics Data System (ADS)

Sorvari, S.; Glaves, H.

2017-12-01

There has been a national geoscience repository at the British Geological Survey (or one of its previous incarnations) almost since its inception in 1835. This longevity has resulted in vast amounts of analogue material and, more recently, digital data some of which has been collected by our scientists but much more has been acquired either through various legislative obligations or donated from various sources. However, the role and operation of the UK National Geoscience Data Centre (NGDC) in the 21st Century is very different to that of the past, with new systems and procedures dealing with predominantly digital data. A web-based ingestion portal allows users to submit their data directly to the NGDC while online services provide discovery and access to data and derived products. Increasingly we are also required to implement an array of standards e.g. ISO, OGC, W3C, best practices e.g. FAIR and legislation e.g. EU INSPIRE Directive; whilst at the same time needing to justifying our very existence to our funding agency and hosting organisation. External pressures to demonstrate that we can be recognised as a trusted repository by researchers, various funding agencies, publishers and other related entities have forced us to look at how we function, and to benchmark our operations against those of other organisations and current relevant standards such as those laid down by different repository certification processes. Following an assessment of the various options, the WDS/DSA certification process was selected as the most appropriate route for accreditation of NGDC as a trustworthy repository. It provided a suitable framework for reviewing the current systems, procedures and best practices. Undertaking this process allowed us to identify where the NGDC already has robust systems in place and where there were gaps and deficiencies in current practices. The WDS/DSA assessment process also helped to reinforce best practice throughout the NGDC and demonstrated that many of the recognised and required procedures and standards for recognition as a trusted repository were already in place, even if they were not always followed!

Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland.

PubMed

Koski, Sari M; Laitinen-Parkkonen, Pirjo; Airaksinen, Marja

2015-01-01

The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied. Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products. Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent. Copyright © 2013 John Wiley & Sons, Ltd.

Survey of egg farmers regarding the ban on conventional cages in the EU and their opinion of alternative layer housing systems in Flanders, Belgium.

PubMed

Stadig, L M; Ampe, B A; Van Gansbeke, S; Van den Bogaert, T; D'Haenens, E; Heerkens, J L T; Tuyttens, F A M

2016-03-01

On 1 January 2012, conventional cages for laying hens were banned in the European Union (EU); all egg farmers must now use alternative hen housing systems. In total, 218 Flemish egg farmers were surveyed in 2013 to 2014 regarding which housing systems they currently use, their degree of satisfaction with the system, and how they experienced the transition from conventional cages to an alternative system. The response rate was 58.3% (127 respondents). Of these, 43 (33.9%) were no longer active as an egg farmer, mainly due to the ban on conventional cages. The respondents who were active as egg farmers both before and after the transition (84, 66.1%) mainly judged the ban as negative for their own finances and for the competitive position of the Belgian egg industry, but were neutral or positive regarding the general consequences for their own business. Most respondents' hens were housed in either aviary systems (47.7%) or in alternative cage systems (38.2%). When choosing a new system, the fit into the farm and consumer demand were the most important factors. Consumer demand was the main reason for choosing a system with free-range access. In general, egg farmers were satisfied with the system they chose, although this differs between systems. When asked to compare the alternative systems to conventional cages, alternatives were judged to be better for hen welfare and consumer demand, but similar or worse for all other aspects, especially labor. Egg farmers previously using conventional cages judged alternative systems more negatively than those who had no prior experience with conventional cages. Farmers who had experience with free-range systems judged these more positively than those without this experience, e.g., for egg consumer demand, profitability, and hen welfare. These results can possibly be extrapolated to other EU countries in which conventional cages were the most common housing system until 2012, and lessons can be drawn from the farmers' experiences when implementing other animal welfare legislation that may require similar far-reaching adaptations for primary production. © 2015 Poultry Science Association Inc.

Assessment of toxic metals and phthalates in children's toys and clays.

PubMed

Korfali, Samira I; Sabra, Rayan; Jurdi, Mey; Taleb, Robin I

2013-10-01

Toxic metals and phthalates are introduced in the manufacturing of plastic toys and modeling clays. In Lebanon, inexpensive plastic toys and modeling clays (sold in dollar stores) are affordable and popular, and there is no legislation to monitor or regulate such toys. This study aimed to assess the quality of inexpensive plastic toys and modeling clays imported in Lebanon. Metal concentrations in toys, namely, zinc [not detectable (ND) to 3,708 μg/g], copper (ND to 140), chromium (ND to 75 μg/g), tin (ND to 39 μg/g), and cadmium (Cd) (ND to 20 μg/g), were lower than the European Union (EU) Directive limits, whereas lead (ND to 258 μg/g) in 10% of samples and antimony (Sb) (ND to 195 μg/g) in 5% of samples were greater than the EU limits. In modeling clays, most of the metals were lower than the EU Directive limits except for Cd and arsenic (As). Cd was detected in 83% of samples, with a mean level of 9.1 μg/g, which is far greater than the EU Directive limit (1.9 μg/g). The As mean level of 4.5 μg/g was greater than the EU limit (4.0 μg/g) and was detected in 9% of samples. Phthalic acid esters (PAEs) were found in 60% of children's toys and 77% of modeling clays. Phthalic acid butyl ester had the highest-level PAE encountered and was ≤59.1 % in one type of clay. However, among children's toys, di(4-octyl) ester terephthalic acid was the highest encountered phthalate at a concentration of 25.7%. The community survey indicated that 82% of households purchase their toys from inexpensive shops and that only 17% of parents were aware of the health hazard of such toys. Consequently, an intervention plan was proposed for the provision of safe toys to children.

The Effect of Steps to Promote Higher Levels of Farm Animal Welfare across the EU. Societal versus Animal Scientists’ Perceptions of Animal Welfare

PubMed Central

Averós, Xavier; Aparicio, Miguel A.; Ferrari, Paolo; Guy, Jonathan H.; Hubbard, Carmen; Schmid, Otto; Ilieski, Vlatko; Spoolder, Hans A. M.

2013-01-01

Simple Summary We studied different EU production standards and initiatives to determine whether there is still room or not for further animal welfare improvement, and which should be the best way to achieve it. Many of the adopted measures in these standards and initiatives are scientifically supported, but other aspects that are equally important for animal welfare are not included in any of them. Animal welfare improvement should consider, for each country, those aspects actually benefiting animals, but also the social expectations within each country. Economic constraints might explain the gap between what society demands, and what farm animals actually need. Abstract Information about animal welfare standards and initiatives from eight European countries was collected, grouped, and compared to EU welfare standards to detect those aspects beyond minimum welfare levels demanded by EU welfare legislation. Literature was reviewed to determine the scientific relevance of standards and initiatives, and those aspects going beyond minimum EU standards. Standards and initiatives were assessed to determine their strengths and weaknesses regarding animal welfare. Attitudes of stakeholders in the improvement of animal welfare were determined through a Policy Delphi exercise. Social perception of animal welfare, economic implications of upraising welfare levels, and differences between countries were considered. Literature review revealed that on-farm space allowance, climate control, and environmental enrichment are relevant for all animal categories. Experts’ assessment revealed that on-farm prevention of thermal stress, air quality, and races and passageways’ design were not sufficiently included. Stakeholders considered that housing conditions are particularly relevant regarding animal welfare, and that animal-based and farm-level indicators are fundamental to monitor the progress of animal welfare. The most notable differences between what society offers and what farm animals are likely to need are related to transportation and space availability, with economic constraints being the most plausible explanation. PMID:26479534

Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

PubMed

Goedecke, Thomas; Ord, Kathryn; Newbould, Victoria; Brosch, Sabine; Arlett, Peter

2016-06-01

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article describes the key concepts of the EU good practice guidance for defining, classifying, coding, reporting, evaluating and preventing medication errors. This guidance should contribute to the safe and effective use of medicines for the benefit of patients and public health.

Reprint of: Dream vs. reality: seven case-studies on the desirability and feasibility of cross-border hospital collaboration in Europe.

PubMed

Glinos, Irene A; Baeten, Rita

2015-01-01

Despite being a niche phenomenon, cross-border health care collaboration receives a lot of attention in the EU and figures visibly on the policy agenda, in particular since the policy process which eventually led to the adoption of Directive 2011/24/EU. One of the underlying assumptions is that cross-border collaboration is desirable, providing justification to both the European Commission and to border-region stakeholders for promoting it. The purpose of this paper is to question this assumption and to examine the role of actors in pushing (or not) for cross-border collaboration. The analysis takes place in two parts. First, the EU policies to promote cross-border collaboration and the tools employed are examined, namely (a) use of European funds to sponsor concrete border-region collaboration projects, (b) use of European funds to sponsor research which gives visibility to cross-border collaboration, and (c) use of the European Commission's newly acquired legal mandate to encourage "Member States to cooperate in cross-border health care provision in border-regions" (Art. 10) and support "Member States in the development of European reference networks between health care providers and centres of expertise" (Art. 12). Second, evidence gathered in 2011-2013 from seven European border-regions on hospital cross-border collaboration is systematically reviewed to assess the reality of cross-border collaboration - can it work and when, and why do actors engage in cross-border collaboration? The preliminary findings suggest that while the EU plays a prominent role in some border-region initiatives, cross-border collaboration needs such a specific set of circumstances to work that it is questionable whether it can effectively be promoted. Moreover, local actors make use of the EU (as a source of funding, legislation or legitimisation) to serve their needs. Copyright © 2014. Published by Elsevier Ltd.

Dream vs. reality: seven case-studies on the desirability and feasibility of cross-border hospital collaboration in Europe.

PubMed

Glinos, Irene A; Baeten, Rita

2014-09-01

Despite being a niche phenomenon, cross-border health care collaboration receives a lot of attention in the EU and figures visibly on the policy agenda, in particular since the policy process which eventually led to the adoption of Directive 2011/24/EU. One of the underlying assumptions is that cross-border collaboration is desirable, providing justification to both the European Commission and to border-region stakeholders for promoting it. The purpose of this paper is to question this assumption and to examine the role of actors in pushing (or not) for cross-border collaboration. The analysis takes place in two parts. First, the EU policies to promote cross-border collaboration and the tools employed are examined, namely (a) use of European funds to sponsor concrete border-region collaboration projects, (b) use of European funds to sponsor research which gives visibility to cross-border collaboration, and (c) use of the European Commission's newly acquired legal mandate to encourage "Member States to cooperate in cross-border health care provision in border-regions" (Art. 10) and support "Member States in the development of European reference networks between health care providers and centres of expertise" (Art. 12). Second, evidence gathered in 2011-2013 from seven European border-regions on hospital cross-border collaboration is systematically reviewed to assess the reality of cross-border collaboration - can it work and when, and why do actors engage in cross-border collaboration? The preliminary findings suggest that while the EU plays a prominent role in some border-region initiatives, cross-border collaboration needs such a specific set of circumstances to work that it is questionable whether it can effectively be promoted. Moreover, local actors make use of the EU (as a source of funding, legislation or legitimisation) to serve their needs. Copyright © 2014. Published by Elsevier Ltd.

Adolescents perceived effectiveness of the proposed European graphic tobacco warning labels.

PubMed

Vardavas, Constantine I; Connolly, Gregory; Karamanolis, Kostas; Kafatos, Anthony

2009-04-01

Graphical tobacco product labelling is a prominent source of health information and has an important position among tobacco control initiatives. However, little is known about its effectiveness among adolescents. With this above in mind, we aimed to research into how adolescents perceive the proposed EU graphic tobacco product warning labels as an effective means of preventing smoking initiation in comparison to the current EU text-only warning labels. Five hundred seventy four adolescents (13-18, 54% male) from Greece were privately interviewed, with the use of a digital questionnaire and randomly shown seven existing EU text-only and proposed EU graphic warning labels. Non-smoking respondents were asked to compare and rate the warnings effectiveness in regard to preventing them from smoking on a 1-5 Likert type scale. Irrespective of the warning category shown, on all occasions, non-smoking adolescents rated the suggested EU graphic labels as more effective in preventing them from smoking in comparison to the existing EU text-only warnings. Controlling for gender, age, current smoking status and number of cigarettes smoked per month, younger adolescents were found to opt for graphic warnings more often, and also perceive graphic warning labels as a more effective means of preventing them from smoking, in comparison to their elder peers (P < 0.001). The proposed EU graphic warning labels may play an important role in preventing of smoking initiation during the crucial years of early adolescence when smoking experimentation and early addiction usually take place.

[European community guidelines and standards in indoor air quality: what proposals for Italy].

PubMed

Settimo, Gaetano; D'Alessandro, Daniela

2014-01-01

Indoor air quality is an issue on which to focus because of the increasing number of exposed population and in view of the strong public feeling on this issue. This paper reports the rules of EU and several European countries about indoor air quality, focusing on the initiatives performed in Italy to respond to WHO recommendations. Several EU countries have introduced in their legislation rules relating to indoor air quality. At the moment, in Italy, a reference rule has not been issued. For this reason, up to date main informations concerning some guidelines or reference values in indoor air, to be used for a first comparison, are those obtained by the scientific literature, or by the guidelines issued by other European countries or, for analogy, by other standard values such as limit or reference values regarding outdoor air. Even the EU, while reaffirming the priority of energy efficiency measures, recommends healthier indoor environments and the development of a specific European strategy on the issue of indoor air quality. The National Study Group on indoor pollution of the Italian National Health Institute (ISS), is working for the development of shared technical and scientific documents, in order to provide greater uniformity of actions at national level, waiting for a legal framework for indoor air quality, in the light of the indication already produced by the WHO.

Changes in radiological protection and quality control in Spanish dental installations: 1996-2003.

PubMed

Alcaraz-Baños, Miguel; Parra-Pérez, María del Carmen; Armero-Barranco, David; Velasco-Hidalgo, Francisco; Velasco-Hidalgo, Esteban

2009-10-01

The European Union has established specific directives concerning radiological protection which are obligatory for member States. In addition, all Spanish dental clinics with radiological equipment are required to have an annual quality control check. To analyze the effect of new European legislation on dental radiological practice in Spain and to determine whether it has resulted in lower doses being administered to patients. A total of 10,171 official radiological quality control reports on Spanish dental clinics, covering 16 autonomous regions, were studied following the passing of Royal Decree 2071/1995 on quality criteria in radiodiagnostic installations. The reports, compiled by U.T.P.R Asigma S.A., a company authorised by the Nuclear Safety Council, cover the years 1996 to 2003, which has enabled us to monitor the evolution of radiological procedures in dental clinics over a seven year period. According to the reports for 2003, 77.3 % of clinics complied with EU requirements, using equipment of 70 kVp, 8 mA, 1.5 mm Al filters, with a collimator length of 20 cm. However, non-compliance was detected in approximately a third (30.8%) of the equipment inspected: alterations in the kilovoltage used, exposure time, performance of the tubing, dosage, linearity/intensity of current and acoustic-luminous signal 6.86%. The mean skin dose reached 3.11 mGy for patients who received an x-ray of an upper molar, representing a decrease of 18% over the seven years studied. there has obviously been a general improvement in the parameters studied, but only 77.3% of the installations complied fully with official EU regulations concerning dental radiological protection.

Synthesis and photoluminescence properties of a cyan-emitting phosphor Ca3(PO4)2:Eu2+ for white light-emitting diodes

NASA Astrophysics Data System (ADS)

Zhou, Wenli; Han, Jin; Zhang, Xuejie; Qiu, Zhongxian; Xie, Qingji; Liang, Hongbin; Lian, Shixun; Wang, Jing

2015-01-01

In this paper, a cyan-emitting phosphor Ca3(PO4)2:Eu2+ (TCP:Eu2+) was synthesized and evaluated as a candidate for white light emitting diodes (WLEDs). This phosphor shows strong and broad absorption in 250-450 nm region, but the emission spectrum is prominent at around 480 nm. The emission intensity of the TCP:Eu2+ was found to be 60% and 82% of that of the commercial BaMgAl10O17:Eu2+ (BAM) under excitation at 340 nm and 370 nm, respectively. Upon excitation at 370 nm, the absolute internal and external quantum efficiencies of the Ca3(PO4)2:1.5%Eu2+ are 60% and 42%, respectively. Moreover, a white LED lamp was fabricated by coating TCP:Eu2+ with a blue-emitting BAM and a red-emitting CaAlSiN3:Eu2+ on a near-ultraviolet (375 nm) LED chip, driven by a 350 mA forward bias current, and it produces an intense white light with a color rendering index of 75.

Synthesis, structure, and luminescence properties of SrSiAl2O3N2:Eu(2+) phosphors for light-emitting devices and field emission displays.

PubMed

Wang, Xicheng; Zhao, Zhengyan; Wu, Quansheng; Li, Yanyan; Wang, Chuang; Mao, Aijun; Wang, Yuhua

2015-06-28

A series of SrSiAl2O3N2:Eu(2+) (0.005 ≤x≤ 0.05) phosphors were successfully synthesized through a pressureless, facile, and efficient solid state route. The crystal structure, band structure, and their photoluminescence and cathodoluminescence properties were investigated in detail. The phosphors exhibit rod shape morphology with a uniform Eu(2+) distribution. Under n-UV excitation the emission spectra shift from 477 to 497 nm with an increase of Eu(2+) concentration. The concentration quenching mechanism of Eu(2+) emission was dominated by the dipole-dipole interaction. The thermal stability is comparable to that of the commercial Ba2SiO4:Eu(2+) phosphor. The phosphor also exhibits high current saturation and high resistance under low voltage electron bombardment. All the results indicate that the SrSiAl2O3N2:Eu(2+) phosphors can be considered as candidates for application in both white LEDs and FEDs.

New GMO regulations for old: Determining a new future for EU crop biotechnology.

PubMed

Davison, John; Ammann, Klaus

2017-01-02

In this review, current EU GMO regulations are subjected to a point-by point analysis to determine their suitability for agriculture in modern Europe. Our analysis concerns present GMO regulations as well as suggestions for possible new regulations for genome editing and New Breeding Techniques (for which no regulations presently exist). Firstly, the present GMO regulations stem from the early days of recombinant DNA and are not adapted to current scientific understanding on this subject. Scientific understanding of GMOs has changed and these regulations are now, not only unfit for their original purpose, but, the purpose itself is now no longer scientifically valid. Indeed, they defy scientific, economic, and even common, sense. A major EU regulatory preconception is that GM crops are basically different from their parent crops. Thus, the EU regulations are "process based" regulations that discriminate against GMOs simply because they are GMOs. However current scientific evidence shows a blending of classical crops and their GMO counterparts with no clear demarcation line between them. Canada has a "product based" approach and determines the safety of each new crop variety independently of the process used to obtain it. We advise that the EC re-writes it outdated regulations and moves toward such a product based approach.  Secondly, over the last few years new genomic editing techniques (sometimes called New Breeding Techniques) have evolved. These techniques are basically mutagenesis techniques that can generate genomic diversity and have vast potential for crop improvement. They are not GMO based techniques (any more than mutagenesis is a GMO technique), since in many cases no new DNA is introduced. Thus they cannot simply be lumped together with GMOs (as many anti-GMO NGOs would prefer). The EU currently has no regulations to cover these new techniques. In this review, we make suggestions as to how these new gene edited crops may be regulated. The EU is at a turning point where the wrong decision could destroy European agricultural competitively for decades to come.

A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors

PubMed Central

Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R

2013-01-01

We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. PMID:23362829

JRC GMO-Amplicons: a collection of nucleic acid sequences related to genetically modified organisms

PubMed Central

Petrillo, Mauro; Angers-Loustau, Alexandre; Henriksson, Peter; Bonfini, Laura; Patak, Alex; Kreysa, Joachim

2015-01-01

The DNA target sequence is the key element in designing detection methods for genetically modified organisms (GMOs). Unfortunately this information is frequently lacking, especially for unauthorized GMOs. In addition, patent sequences are generally poorly annotated, buried in complex and extensive documentation and hard to link to the corresponding GM event. Here, we present the JRC GMO-Amplicons, a database of amplicons collected by screening public nucleotide sequence databanks by in silico determination of PCR amplification with reference methods for GMO analysis. The European Union Reference Laboratory for Genetically Modified Food and Feed (EU-RL GMFF) provides these methods in the GMOMETHODS database to support enforcement of EU legislation and GM food/feed control. The JRC GMO-Amplicons database is composed of more than 240 000 amplicons, which can be easily accessed and screened through a web interface. To our knowledge, this is the first attempt at pooling and collecting publicly available sequences related to GMOs in food and feed. The JRC GMO-Amplicons supports control laboratories in the design and assessment of GMO methods, providing inter-alia in silico prediction of primers specificity and GM targets coverage. The new tool can assist the laboratories in the analysis of complex issues, such as the detection and identification of unauthorized GMOs. Notably, the JRC GMO-Amplicons database allows the retrieval and characterization of GMO-related sequences included in patents documentation. Finally, it can help annotating poorly described GM sequences and identifying new relevant GMO-related sequences in public databases. The JRC GMO-Amplicons is freely accessible through a web-based portal that is hosted on the EU-RL GMFF website. Database URL: http://gmo-crl.jrc.ec.europa.eu/jrcgmoamplicons/ PMID:26424080

JRC GMO-Amplicons: a collection of nucleic acid sequences related to genetically modified organisms.

PubMed

Petrillo, Mauro; Angers-Loustau, Alexandre; Henriksson, Peter; Bonfini, Laura; Patak, Alex; Kreysa, Joachim

2015-01-01

The DNA target sequence is the key element in designing detection methods for genetically modified organisms (GMOs). Unfortunately this information is frequently lacking, especially for unauthorized GMOs. In addition, patent sequences are generally poorly annotated, buried in complex and extensive documentation and hard to link to the corresponding GM event. Here, we present the JRC GMO-Amplicons, a database of amplicons collected by screening public nucleotide sequence databanks by in silico determination of PCR amplification with reference methods for GMO analysis. The European Union Reference Laboratory for Genetically Modified Food and Feed (EU-RL GMFF) provides these methods in the GMOMETHODS database to support enforcement of EU legislation and GM food/feed control. The JRC GMO-Amplicons database is composed of more than 240 000 amplicons, which can be easily accessed and screened through a web interface. To our knowledge, this is the first attempt at pooling and collecting publicly available sequences related to GMOs in food and feed. The JRC GMO-Amplicons supports control laboratories in the design and assessment of GMO methods, providing inter-alia in silico prediction of primers specificity and GM targets coverage. The new tool can assist the laboratories in the analysis of complex issues, such as the detection and identification of unauthorized GMOs. Notably, the JRC GMO-Amplicons database allows the retrieval and characterization of GMO-related sequences included in patents documentation. Finally, it can help annotating poorly described GM sequences and identifying new relevant GMO-related sequences in public databases. The JRC GMO-Amplicons is freely accessible through a web-based portal that is hosted on the EU-RL GMFF website. Database URL: http://gmo-crl.jrc.ec.europa.eu/jrcgmoamplicons/. © The Author(s) 2015. Published by Oxford University Press.

A modern solid waste management strategy--the generation of new by-products.

PubMed

Fudala-Ksiazek, Sylwia; Pierpaoli, Mattia; Kulbat, Eliza; Luczkiewicz, Aneta

2016-03-01

To benefit the environment and society, EU legislation has introduced a 'zero waste' strategy, in which waste material should be converted to resources. Such legislation is supported by the solid waste hierarchy concept, which is a set of priorities in waste management. Under this concept, municipal solid waste plants (MSWPs) should be equipped with sorting and recycling facilities, composting/incineration units and landfill prisms for residual bulk disposal. However, each of the aforementioned facilities generates by-products that must be treated. This project focuses on the leachates from landfill prisms, including modern prism (MP) that meet EU requirements and previous prism (PP) that provide for the storage of permitted biodegradable waste as well as technological wastewaters from sorting unit (SU) and composting unit (CU), which are usually overlooked. The physico-chemical parameters of the liquid by-products collected over 38 months were supported by quantitative real-time PCR (qPCR) amplifications of functional genes transcripts and a metagenomic approach that describes the archaeal and bacterial community in the MP. The obtained data show that SU and especially CU generate wastewater that is rich in nutrients, organic matter and heavy metals. Through their on-site pre-treatment and recirculation via landfill prisms, the landfill waste decomposition process may be accelerated because of the introduction of organic matter and greenhouse gas emissions may be increased. These results have been confirmed by the progressive abundance of both archaeal community and the methyl coenzyme M reductase (mcrA) gene. The resulting multivariate data set, supported by a principal component analysis, provides useful information for the design, operation and risk assessment of modern MSWPs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Photoluminescence and doping mechanism of theranostic Eu3+/Fe3+ dual-doped hydroxyapatite nanoparticles.

PubMed

Chen, Min-Hua; Yoshioka, Tomohiko; Ikoma, Toshiyuki; Hanagata, Nobutaka; Lin, Feng-Huei; Tanaka, Junzo

2014-10-01

Theranostic nanoparticles currently have been regarded as an emerging concept of 'personalized medicine' with diagnostic and therapeutic dual-functions. Eu 3+ doped hydroxyapatite (HAp) has been regarded as a promising fluorescent probe for in vivo imaging applications. Additionally, substitution of Ca 2+ with Fe 3+ in HAp crystal may endow the capability of producing heat upon exposure to a magnetic field. Here we report a preliminary study of doping mechanism and photoluminescence of Eu 3+ and Fe 3+ doped HAp nanoparticles (Eu/Fe:HAp). HAp with varied concentration of Eu 3+ and Fe 3+ doping are presented as Eu(10 mol%):HAp, Eu(7 mol%)-Fe(3 mol%):HAp, Eu(5 mol%)-Fe(5 mol%):HAp, Eu(3 mol%)-Fe(7 mol%):HAp, and Fe(10 mol%):HAp in the study. The results showed that the HAp particles, in nano-size with rod-like morphology, were successfully doped with Eu 3+ and Fe 3+ , and the particles can be well suspended in cell culture medium. Photoluminescence analysis revealed that particles have prominent emissions at 536 nm, 590 nm, 615 nm, 650 nm and 695 nm upon excitation at a wavelength of 397 nm. Moreover, these Eu/Fe:HAp nanoparticles belonged to B-type carbonated HAp, which has been considered an effective biodegradable and biocompatible drug/gene carrier in biological applications.

Photoluminescence and doping mechanism of theranostic Eu3+/Fe3+ dual-doped hydroxyapatite nanoparticles

NASA Astrophysics Data System (ADS)

Chen, Min-Hua; Yoshioka, Tomohiko; Ikoma, Toshiyuki; Hanagata, Nobutaka; Lin, Feng-Huei; Tanaka, Junzo

2014-10-01

Theranostic nanoparticles currently have been regarded as an emerging concept of ‘personalized medicine’ with diagnostic and therapeutic dual-functions. Eu3+ doped hydroxyapatite (HAp) has been regarded as a promising fluorescent probe for in vivo imaging applications. Additionally, substitution of Ca2+ with Fe3+ in HAp crystal may endow the capability of producing heat upon exposure to a magnetic field. Here we report a preliminary study of doping mechanism and photoluminescence of Eu3+ and Fe3+ doped HAp nanoparticles (Eu/Fe:HAp). HAp with varied concentration of Eu3+ and Fe3+ doping are presented as Eu(10 mol%):HAp, Eu(7 mol%)-Fe(3 mol%):HAp, Eu(5 mol%)-Fe(5 mol%):HAp, Eu(3 mol%)-Fe(7 mol%):HAp, and Fe(10 mol%):HAp in the study. The results showed that the HAp particles, in nano-size with rod-like morphology, were successfully doped with Eu3+ and Fe3+, and the particles can be well suspended in cell culture medium. Photoluminescence analysis revealed that particles have prominent emissions at 536 nm, 590 nm, 615 nm, 650 nm and 695 nm upon excitation at a wavelength of 397 nm. Moreover, these Eu/Fe:HAp nanoparticles belonged to B-type carbonated HAp, which has been considered an effective biodegradable and biocompatible drug/gene carrier in biological applications.

Day-to-day management of EU projects: Implementation of a local manager network to secure knowledge transfer

NASA Astrophysics Data System (ADS)

Hoffmann, Friederike; Meyer, Stefanie; de Vareilles, Mahaut

2017-04-01

In the past years there has been a strong push in Norway for increasing participation in the EU Framework Programmes for Research and Innovation. EU projects coordinated by the University of Bergen (UiB) usually receive management support from the central administration (mostly financial) in collaboration with a full- or part-time scientific project manager working on a fixed-term contract at the same institute as the project's principal scientist. With an increasing amount of granted EU projects, the number of scientific project managers employed across the whole university has also increased, and a need for coordination and professionalization of this service became obvious. Until recently, UiB had no unified structures and routines for training of newly recruited project managers, or for archiving and transferring routines and skills after the end of the project and the manager's employment contract. To overcome this administrative knowledge gap, the "Forum for scientific EU project managers at UiB" was founded in spring 2016 as an informal communication platform. Its purpose is to bring together current and previous scientific EU project managers from different disciplines to share their experiences. The main aim of the forum is to transfer and improve knowledge, skills and routines on effective management of EU funded projects, but also to function as a discussion forum where issues arising from handling international consortia can be reviewed. The group meets monthly and discusses current challenges from on-going EU projects as well as routines for specific project operation tasks. These routines are archived in an online best-practise guide which the group currently develops. The regular personal meetings are supplemented with an intense communication via a group mailing list and several individual mail- and phone-meetings. Since lessons learned during project implementation may improve future proposals, UiB research advisors for proposal support frequently interact with the members of the forum. The forum is also used to spread relevant information received from other sources. We already realize that the forum and its products lead to increased competence of scientific EU project managers and research advisors at UiB. To further harvest these synergy effects, we aim to increase our interaction with similar groups, networks, and online platforms in and beyond Europe.

[Quality of hospital discharge reports in terms of current legislation and expert recommendations].

PubMed

Zambrana-García, José Luis; Rivas-Ruiz, Francisco

2013-01-01

To determine the quality of hospital discharge reports (HDRs) taking into account current legislation and the conclusions of the consensus on hospital discharge reports in medical specialities in 11 community hospitals in Andalusia (Spain). A cross-sectional study of 1,708 HDRs was carried out. We determined the presence or absence of the various items required by current legislation and by the recommendations of the above-mentioned consensus. A total of 97.4% (95% confidence interval [95% CI]: 96.5-98.2) of the HDRs were classified as satisfactory according to the stipulations of current legislation. However, when the assessment was based on the consensus, the rate of adequacy fell to 72.1% (95% CI: 70.0-74.3). A notable finding was the absence of the duration of treatment after hospital discharge in 39.4% of the HDRs. HDRs show an excellent level of compliance with the data required by current regulations, but their intrinsic quality needs to be improved. Copyright © 2012 SESPAS. Published by Elsevier Espana. All rights reserved.

Regenerative medicine in Europe: global competition and innovation governance.

PubMed

Hogarth, Stuart; Salter, Brian

2010-11-01

Leading European nations with strong biotech sectors, such as the UK and Germany, are investing heavily in regenerative medicine, seeking competitive advantage in this emerging sector. However, in the broader biopharmaceutical sector, the EU is outperformed by the USA on all metrics, reflecting longstanding problems: limited venture capital finance, a fragmented patent system, and relatively weak relations between academia and industry. The current global downturn has exacerbated these difficulties. The crisis comes at a time when the EU is reframing its approach to the governance of innovation and renewing its commitment to the goal of making Europe the leading player in the global knowledge economy. If the EU is to gain a competitive advantage in the regenerative medicine sector then it must coordinate a complex multilevel governance framework that encompasses the EU, member states and regional authorities. This article takes stock of Europe's current competitive position within the global bioeconomy, drawing on a variety of metrics in the three intersecting spheres of innovation governance: science, market and society. These data then provide a platform for reviewing the problems of innovation governance faced by the EU and the strategic choices that have to be confronted in the regenerative medicine sector.

Monitoring, sources, receptors, and control measures for three European Union watch list substances of emerging concern in receiving waters - A 20year systematic review.

PubMed

Tiedeken, Erin Jo; Tahar, Alexandre; McHugh, Brendan; Rowan, Neil J

2017-01-01

Pollution of European receiving waters with contaminants of emerging concern (CECs), such as with 17-beta-estradiol (a natural estrogenic hormone, E2), along with pharmaceutically-active compounds diclofenac (an anti-inflammatory drug, DCL) and 17-alpha-ethynylestradiol (a synthetic estrogenic hormone, EE2)) is a ubiquitous phenomenon. These three CECs were added to the EU watch list of emerging substances to be monitoring in 2013, which was updated in 2015 to comprise 10 substances/groups of substances in the field of water policy. A systematic literature review was conducted of 3952 potentially relevant articles over period 1995 to 2015 that produced a new EU-wide database consisting of 1268 publications on DCL, E2 and EE2. European surface water concentrations of DCL are typically reported below the proposed annual average environmental quality standard (AA EQS) of 100ng/l, but that exceedances frequently occur. E2 and EE2 surface water concentrations are typically below 50ng/l and 10ng/l respectively, but these values greatly exceed the proposed AA EQS values for these compounds (0.04 and 0.035ng/l respectively). However, levels of these CECs are frequently reported to be disproportionately high in EU receiving waters, particularly in effluents at control points that require urgent attention. Overall it was found that DCL and EE2 enter European aquatic environment mainly following human consumption and excretion of therapeutic drugs, and by incomplete removal from influent at urban wastewater treatment plants (WWTPs). E2 is a natural hormone excreted by humans which also experiences incomplete removal during WWTPs treatment. Current conventional analytical chemistry methods are sufficiently sensitive for the detection and quantification of DCL but not for E2 and EE2, thus alternative, ultra-trace, time-integrated monitoring techniques such as passive sampling are needed to inform water quality for these estrogens. DCL appears resistant to conventional wastewater treatment while E2 and EE2 have high removal efficiencies that occur through biodegradation or sorption to organic matter. There is a pressing need to determine fate and behaviour of these CECs in European receiving waters such as using GIS-modelling of river basins as this will identify pressure points for informing priority decision making and alleviation strategies for upgrade of WWTPs and for hospital effluents with advanced treatment technologies. More monitoring data for these CECs in receiving waters is urgently needed for EU legislation and effective risk management. Copyright © 2016 Elsevier B.V. All rights reserved.

Preferential Eu Site Occupation and Its Consequences in the Ternary Luminescent Halides AB 2 I 5 : Eu 2 + ( A = Li – Cs ; B = Sr , Ba)

DOE PAGES

Fang, C.  M.; Biswas, Koushik

2015-07-22

Several rare-earth-doped, heavy-metal halides have recently been identified as potential next-generation luminescent materials with high efficiency at low cost. AB 2I 5:Eu 2+ (A=Li–Cs; B=Sr, Ba) is one such family of halides. Its members, such as CsBa 2I 5:Eu 2+ and KSr 2I 5:Eu 2+, are currently being investigated as high-performance scintillators with improved sensitivity, light yield, and energy resolution less than 3% at 662 keV. Within the AB 2I 5 family, our first-principles-based calculations reveal two remarkably different trends in Eu site occupation. The substitutional Eu ions occupy both eightfold-coordinated B1(VIII) and the sevenfold-coordinated B2(VII) sites in the Sr-containingmore » compounds. However, in the Ba-containing crystals, Eu ions strongly prefer the B2(VII)sites. This random versus preferential distribution of Eu affects their electronic properties. The calculations also suggest that in the Ba-containing compounds one can expect the formation of Eu-rich domains. These results provide atomistic insight into recent experimental observations about the concentration and temperature effects in Eu-doped CsBa 2I 5. We discuss the implications of our results with respect to luminescent properties and applications. We also hypothesize Sr, Ba-mixed quaternary iodides ABa VIIISr VIII 5:Eu as scintillators having enhanced homogeneity and electronic properties.« less

Are evolving human rights harmless? An examination of English legislation, prostitution and its effect on human relatedness.

PubMed

Westin, Anna

2014-01-01

This paper addresses key philosophical and social questions that shape the contemporary discourse on prostitution. The initial section outlines the contemporary challenges facing legislative practice on prostitution in England. This involves analysing moral and legal framework surrounding prostitution that has made the current legislative dilemma surrounding prostitution practice possible. The second part of the paper then outlines the history of the philosophy of human rights from Aquinas to the Universal Declaration of Human Rights (1948). The paper concludes by analysing whether the current ontology employed by human rights theory is effective in creating a system of just relatedness between agents, made visible in concrete legislative guidance. I argue that legislation guided by a fragmented teleology and ontological anthropology enables asymmetrical patterns of relatedness that can cause genuine physical and psychological harm to individuals.

Model Legislation for GAAP and GASB.

ERIC Educational Resources Information Center

Bissell, George E.

1987-01-01

The use of generally accepted accounting principles (GAAP) by all state and local governments may require legislation. Findings from a survey of states to get data on current accounting and financial reporting practices are summarized. Model legislation to provide uniformity in accounting and reporting is presented. (MLF)

EU FP7 project 'CAMbrella' to build European research network for complementary and alternative medicine.

PubMed

Weidenhammer, Wolfgang; Lewith, George; Falkenberg, Torkel; Fønnebø, Vinjar; Johannessen, Helle; Reiter, Bettina; Uehleke, Bernhard; von Ammon, Klaus; Baumhöfener, Franziska; Brinkhaus, Benno

2011-01-01

The status of complementary and alternative medicine (CAM) within the EU needs clarification. The definition and terminology of CAM is heterogeneous. The therapies, legal status, regulations and approaches used vary from country to country but there is widespread use by EU citizens. A coordination project funded by the EU has been launched to improve the knowledge about CAM in Europe. The project aims to evaluate the conditions surrounding CAM use and provision in Europe and to develop a roadmap for European CAM research. Specific objectives are to establish an EU network involving centres of research excellence for collaborative projects, to develop consensus-based terminology to describe CAM interventions, to create a knowledge base that facilitates the understanding of patient demand for CAM and its prevalence, to review the current legal status and policies governing CAM provision, and to explore the needs and attitudes of EU citizens with respect to CAM. Based on this information a roadmap will be created that will enable sustainable and prioritised future European research in CAM. CAMbrella encompasses 16 academic research groups from 12 European countries and will run for 36 months starting from January 2010. The project will be delivered in 9 work packages coordinated by a Management Board and directed by a Scientific Steering Committee with support of an Advisory Board. The outcomes generated will be disseminated through the project's website, peer review open access publications and a final conference, with emphasis on current and future EU policies, addressing different target audiences. Copyright © 2011 S. Karger AG, Basel.

Burnout syndrome as an occupational disease in the European Union: an exploratory study.

PubMed

Lastovkova, Andrea; Carder, Melanie; Rasmussen, Hans Martin; Sjoberg, Lars; Groene, Gerda J de; Sauni, Riitta; Vevoda, Jiri; Vevodova, Sarka; Lasfargues, Gerard; Svartengren, Magnus; Varga, Marek; Colosio, Claudio; Pelclova, Daniela

2018-04-07

The risk of psychological disorders influencing the health of workers increases in accordance with growing requirements on employees across various professions. This study aimed to compare approaches to the burnout syndrome in European countries. A questionnaire focusing on stress-related occupational diseases was distributed to national experts of 28 European Union countries. A total of 23 countries responded. In 9 countries (Denmark, Estonia, France, Hungary, Latvia, Netherlands, Portugal, Slovakia and Sweden) burnout syndrome may be acknowledged as an occupational disease. Latvia has burnout syndrome explicitly included on the List of ODs. Compensation for burnout syndrome has been awarded in Denmark, France, Latvia, Portugal and Sweden. Only in 39% of the countries a possibility to acknowledge burnout syndrome as an occupational disease exists, with most of compensated cases only occurring in recent years. New systems to collect data on suspected cases have been developed reflecting the growing recognition of the impact of the psychosocial work environment. In agreement with the EU legislation, all EU countries in the study have an action plan to prevent stress at the workplace.

Risks related to the introduction of exotic diseases: a European view.

PubMed

Janssen, J; Marchant, B

1995-12-01

The European Union (EU) has historically been free of a number of epidemic diseases of livestock and is approaching eradication of several others. This situation is put at risk by the importation of live animals and animal products. Animal products include products which are broadly described as veterinary biologicals. For the purposes of assessing and controlling risks, these fall into two groups: crude products (e.g. serum and other blood products) and medicinal products (e.g. vaccines and other immunological products). This second group is covered by another paper in this issue of the Review. Risk reduction methods may be applied to crude veterinary biologicals pre- or post-importation. Pre-importation methods include product treatment, or ensuring that the source of the product is "risk-free'. Post-importation risk reduction involves product testing, or treatment achieved by channelling products to commercial operations which are covered by European medicines legislation. At present, EU Member States issue health certificates individually for crude veterinary biologicals, and conditions for entry may differ between States. This process will soon be harmonised (the provisions for marketing medicinal products have already been harmonised).

[Harmonisation of personal injury compensation in the European Union. Application to medical liability case law].

PubMed

Hureau, Jacques

2006-03-01

Harmonisation of personal injury compensation in the European Union (EU) is crucial. Continuing on from the work begun by the European Federation of Medical Academies, a working party of the XVth Committee of the French National Academy of Medicine has sought to go beyond the restrictive framework of automobile accident compensation in order to address more universal concerns, regardless of the causes and effects of bodily injury. The specific situation of injuries resulting from medical acts was considered, both for its medicolegal complexity and its potential human consequences. After recalling relevant European legislation, the authors consider the different philosophies of medical liability and health care systems in Europe. Methodological convergence is required to achieve harmonisation of personal injury compensation regimes, and especially for the classification of different types of bodily injury, the role of social services, and the establishment of a reference for medical evaluation of injury with built-in compensation levels. The doctrines and concepts of all EU member states (civil law, common law, Nordic medical liability regimes, etc.) are discussed, together with means of facilitating their harmonisation.

A description of the standardized measurement procedures and recommended threshold limit values for biological hazards in Germany.

PubMed

Rieger, M A; Lohmeyer, M; Nübling, M; Neuhaus, S; Diefenbach, H; Hofmann, F

2005-05-01

On the basis of EU directives 89/391/EEC (to encourage improvements in the safety and health of workers at work) and 2000/54/EC (on the protection of workers from risks related to exposure to biological agents at work), biological hazards at work have to be assessed and preventive measures have to be introduced in all member states of the EU. In Germany, national legislation (Biological Agents Ordinance - BioStoffV and Technical Rules on Biological Agents, TRBA) and recommendations of workers' compensation boards define standardized methods for the assessment of airborne mold, bacteria, and endotoxins. This article describes policies and practices in Germany for measurement of airborne bioaerosols and for interpretation of measurements relative to the standards. As an example, methods and results of measurements in agriculture are shown. The standardized measurement procedures proved suitable for use in livestock buildings. The results of the exploratory measurements in different livestock buildings confirmed the often high concentrations of airborne biological hazards in agriculture that are reported in the literature.

Europium s-process Signature at Close-to-solar Metallicity in Stardust SiC Grains from Asymptotic Giant Branch Stars

NASA Astrophysics Data System (ADS)

Ávila, Janaína N.; Ireland, Trevor R.; Lugaro, Maria; Gyngard, Frank; Zinner, Ernst; Cristallo, Sergio; Holden, Peter; Rauscher, Thomas

2013-05-01

Individual mainstream stardust silicon carbide (SiC) grains and a SiC-enriched bulk sample from the Murchison carbonaceous meteorite have been analyzed by the Sensitive High Resolution Ion Microprobe-Reverse Geometry for Eu isotopes. The mainstream grains are believed to have condensed in the outflows of ~1.5-3 M ⊙ carbon-rich asymptotic giant branch (AGB) stars with close-to-solar metallicity. The 151Eu fractions [fr(151Eu) = 151Eu/(151Eu+153Eu)] derived from our measurements are compared with previous astronomical observations of carbon-enhanced metal-poor stars enriched in elements made by slow neutron captures (the s-process). Despite the difference in metallicity between the parent stars of the grains and the metal-poor stars, the fr(151Eu) values derived from our measurements agree well with fr(151Eu) values derived from astronomical observations. We have also compared the SiC data with theoretical predictions of the evolution of Eu isotopic ratios in the envelope of AGB stars. Because of the low Eu abundances in the SiC grains, the fr(151Eu) values derived from our measurements show large uncertainties, in most cases being larger than the difference between solar and predicted fr(151Eu) values. The SiC aggregate yields a fr(151Eu) value within the range observed in the single grains and provides a more precise result (fr(151Eu) = 0.54 ± 0.03, 95% conf.), but is approximately 12% higher than current s-process predictions. The AGB models can match the SiC data if we use an improved formalism to evaluate the contribution of excited nuclear states in the calculation of the 151Sm(n, γ) stellar reaction rate.

Designer Drug (DD) abuse in Poland; a review of the psychoactive and toxic properties of substances found from seizures of illegal drug products and the legal consequences thereof. Part 1--cannabinoids and cathinones.

PubMed

Biliński, Przemysław; Hołownia, Piotr; Kapka-Skrzypczak, Lucyna; Wojtyła, Andrzej

2012-01-01

Faced with the rapidly growing increase of designer drug abuse, particularly amongst the younger generation, various legislative strategies are currently employed world-wide for tackling this problem - however with mixed results. The key issue is that the producers of DDs are able to either exploit existing legal substances intended for other uses, but which have been found to possess psychoactive properties, or to synthesise new psychoactive substances by introducing chemical modifications, often very minor ones, thereby avoiding the prohibited use of chemicals included on any banned lists. Some countries opt to ban new drugs as and when shown or considered to be harmful, while others introduce sweeping bans based on chemical structure. Nevertheless, an ever increasing diversity of new DDs are constantly appearing on domestic and Internet markets. Poland, together with the UK and Eire, has placed temporary bans on all DDs whenever they have been identified, thus enabling sufficient time for assessing their potential hazards to health. Part of this 'holding' strategy entails a thorough review of the scientific literature, including expert opinion when direct evidence is lacking, as well as information received from EU support organisations Europol and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). This paper, in two parts, therefore aims to provide an up-to-date summary review of available scientific evidence on the harm caused by the six main chemical groupings of DDs found in drug seizures of illegal products recently made in Poland. The first part is devoted to Cannabinoids and Cathinones derivatives. Ensuing legislation can therefore be rapidly formulated to make the bans permanent as appropriate.

Dog bite injuries to humans and the use of breed-specific legislation: a comparison of bites from legislated and non-legislated dog breeds.

PubMed

Creedon, Nanci; Ó'Súilleabháin, Páraic S

2017-01-01

The primary objective of this study was to investigate if differences in dog bite characteristics exist amongst legislated and non-legislated dog breeds listed under breed-specific legislation in Ireland (age when bitten, anatomical bite locations, triggers for biting, victim's relationship with the dog, geographical location and owner presence, history of aggression, reporting bite incident to authorities, medical treatment required following the bite, and type of bite inflicted). A second objective of the current study was to investigate dog control officer's enforcement and perceptions of current legislation. Data for statistical analyses were collated through a nationally advertised survey, with Pearson Chi-square and Fisher's Exact Test statistical methods employed for analyses. A total of 140 incident surveys were assessed comprising of non-legislated ( n  = 100) and legislated ( n  = 40) dog bite incidents. Legislated breeds were significantly more likely to be perceived as aggressive and less fearful as triggers for biting compared to non-legislated breeds ( P  = 0.003). Non-legislated breeds were more likely to inflict a bite with the owner present on own property and on a business premises compared to legislated breeds ( P  = 0.036). Non-legislated breeds were more likely to not be reported to the authorities before ( P  = 0.009), and after ( P  = 0.032) the bite occurred compared to legislated breeds. There were no significant differences observed between both groups for; age when the victim was bitten, bite location, relationship with the dog, history of aggression, outcome for the dog, if the dog bit again, and seeing a professional trainer or behaviourist. No significant difference was observed between both legislated and non-legislated groups for medical treatment required following the bite, and the type of bite inflicted. The present study results did not observe evidence of any differences between legislated and non-legislated for both the medical treatment to victims required following the bite, and the type of bite inflicted. The significant differences in bites being reported to authorities, perceived triggers for biting, and biting locations suggests distinctly differing perceptions relating to risk between legislated and non-legislated dog breeds. Further consequences relating to the introduction of breed-specific legislation in Ireland are discussed.

Current Legal I-O Issues.

ERIC Educational Resources Information Center

Ofsanko, Frank

This report focuses on a myriad of national, state, and local laws, regulations and court decisions which govern the everyday work of industrial and organizational psychologists. Legislation already in effect and legislation still pending are discussed. Citing relevant legislation and court decisions throughout the text, the paper addresses such…

Monitoring of hydroxyapatite conversion by luminescence intensity of Eu3+ ions during mineralization of Eu3+-doped β-Ca2SiO4

NASA Astrophysics Data System (ADS)

Zhang, Yin; Chen, Jie; Li, Yadong; Seo, Hyo Jin

2014-11-01

β-Dicalcium silicate (β-Ca2SiO4) doped with Eu3+ was synthesized by sol-gel method. The luminescence intensity of the mineralization products formed during the hydroxyapatite (Ca10(PO4)6(OH)2, HA) conversion of Eu3+-doped β-Ca2SiO4, in 0.25 M K2HPO4 solution, were detected using luminescence spectroscopy. The results indicated that the luminescence intensity of Eu3+ ion gradually depressed with prolonged mineralization time, and it could hardly be detected with the complete transformation from β-Ca2SiO4:Eu3+ to hydroxyapatite. The change of Eu3+ ionic concentrations in the mineralization products and the final solutions after conversion reaction, were further examined using energy-dispersive X-ray and inductively-coupled plasma mass spectrometry, respectively. This suggested that the process of mineralization can be monitored with the luminescence intensity of Eu3+ ions in the mineralization products. The current study will open up a new and simple in vivo avenue for in situ monitoring hydroxyapatite conversion with a fiber luminescence spectrometer.

Impact of European legislation on marketed pesticides--a view from the standpoint of health impact assessment studies.

PubMed

Karabelas, A J; Plakas, K V; Solomou, E S; Drossou, V; Sarigiannis, D A

2009-10-01

The very significant impact of European legislation (Directive 91/414/EEC) on the authorization of plant protection products is reviewed herein, which has resulted in withdrawal of 704 active substances (AS) out of 889 assessed so far. The list of currently approved 276 AS includes 194 AS "existing" in the market before 1993 and 82 "new" AS introduced during the last 15 years. Results of toxicity characterization of the approved AS are also summarized, utilizing several well-known databases. Although significant data gaps exist for a rather large part of the approved AS, it is found that 84 AS are positive for at least one health effect (after chronic and/or acute exposure) including carcinogenicity, reproductive and neuro-developmental disorders, as well as endocrine disruption. The toxicity characterization results of this study are compared to those of recent assessments by other organizations (KemI, the Swedish Chemicals Agency, and the Pesticide Safety Directorate of the UK), where interpretation and use is made of AS "cut-off" criteria foreseen in new EU legislation. These studies report a comparatively smaller AS number with positive toxicity characterization. The possibility of some additional AS withdrawal in the near future, combined with the rather small rate of new AS introduction (approx. 5 per year) suggest that the list of approved AS over the next 10-15 years may not change very drastically. Consideration of the above trends is necessary and instructive in evaluating results of existing health impact assessment (HIA) studies, as well as in planning new ones. Due to the very drastic change in the number and type of marketed AS, that took place within the past 8-9years, it is suggested that new HIA studies (based on epidemiological data after year 2000) should focus on a rather short time frame and, therefore, on appropriate cohort groups, e.g. young children. For the same reason, results of epidemiological studies of the past (involving banned AS) should be carefully interpreted and used with caution.

Promotion of Immunizations for Health Professionals in Europe: A Qualitative Study in Seven European Member States.

PubMed

Dalma, Archontoula; Karnaki, Pania; Baka, Agoritsa; Raftopoulos, Vasilios; Zota, Dina; Veloudaki, Afroditi; Garrison, Amanda; Ellis Montalban, Paloma; Dhanani, Zainub; Linos, Athena

2018-01-01

Health Care Workers (HCWs) are a high-risk group for contracting Vaccine-Preventable Diseases who, despite legislation and guidance, remain undervaccinated. In order to understand their barriers and needs, focus groups were formed with 278 physicians, nurses, infection-control personnel, and policy-makers in 7 EU MS. Several implications for the development of promotional initiatives were identified including the need to overcome organizational barriers, to sensitize HCWs about the importance of immunization and to provide specific up-to-date information about vaccinations covering prevalence of diseases, protection years, side effects, administration times, antibody examinations, costs and immunization settings.

Library Legislation.

ERIC Educational Resources Information Center

Kavass, Igor

Examination of several library legislation models developed to meet the needs of developed and developing nations reveals that our traditional notion of the library's role in society must be abandoned if we wish to reconcile its benefits to its costs. Four models currently exist: many nations, particularly Asian, have no legislation; most nations,…

Weed biocontrol in the EU: from serendipity to strategy

USDA-ARS?s Scientific Manuscript database

Biological control of weeds is a globally-recognized approach to the management of the worst invasive plants in the world. Unfortunately, accidental introduction of agents account for most weed biocontrol in the EU, but do include a number of current or emerging successes. From the redistribution of...

Impact of maximum levels in European legislation on exposure of mycotoxins in dried products: case of aflatoxin B1 and ochratoxin A in nuts and dried fruits.

PubMed

Van de Perre, Evelien; Jacxsens, Liesbeth; Lachat, Carl; El Tahan, Fouad; De Meulenaer, Bruno

2015-01-01

In this study the impact of setting European criteria on exposure to aflatoxin B1 via nuts and figs and ochratoxin A via dried fruits is evaluated for the Belgian population, as an example of the European population. Two different scenarios were evaluated. In scenario 1 all collected literature data are considered, assuming that there is no border control nor legal limits in Europe. In the second scenario, contamination levels above the maximum limits are excluded. The results from scenario 1 demonstrated that if no regulation is in place, AFB1 and OTA concentrations reported in the analysed food can have potential health risk to the population. The estimated exposure of OTA for scenario 2 is below the TDI of 5 ng/kg BW⋅day, indicating that OTA concentrations accepted by EU legislation pose a low risk to the Belgian population. For AFB1, the MOE values of scenario 2 are above 10,000 and can be considered to be of low health concern, based on BDML10 for humans, except for figs (MOE = 5782). This means that for all matrices, with exception of figs, the maximum values of AFB1 in the European legislation are sufficient to be of a low health concern for consumers. Copyright © 2014. Published by Elsevier Ltd.

EU ambition to build the world's leading bioeconomy-Uncertain times demand innovative and sustainable solutions.

PubMed

Bell, John; Paula, Lino; Dodd, Thomas; Németh, Szilvia; Nanou, Christina; Mega, Voula; Campos, Paula

2018-01-25

This article outlines the current context and the development of the European Bioeconomy Strategy. It analyses the current situation, challenges and needs for EU action and concludes with the next steps that the European Commission will undertake to review and update the Bioeconomy Strategy. Bioeconomy offers great opportunities to realising a competitive, circular and sustainable economy with a sound industrial base that is less dependent on fossil carbon. A sustainable bioeconomy also contributes to climate change mitigation, with oceans, forests and soils being major carbon sinks and fostering negative CO 2 emissions. The EU has invested significantly in research and innovation in this field and the European Commission is committed to lead on European bioeconomy strategy. Copyright © 2017 Elsevier B.V. All rights reserved.

[Atomic/ionic fluorescence in microwave plasma torch discharge excited by high current microsecond pulsed hollow cathode lamp-europium atomic/ionic fluorescence spectrometry].

PubMed

Gong, Z; Liang, F; Yang, P; Jin, Q; Huang, B

1999-06-01

Eu atomic and ionic fluorescence spectrometry in microwave plasma torch discharge excited by high current microsecond pulsed hollow cathode lamp (HCMP HCL-MPT AFS/IFS) was studied. Operating conditions were optimized. The best detection limits for AFS and IFS obtained with a desolvated ultrasonic nebulization system were 42.0 ng/mL for Eu I 462.7 nm and 21.8 ng/mL for Eu II 381.97 nm, respectively, both were better than those given by the instruction manual of a Baird ICP AFS-2000 spectrometer using pneumatic concentric nebulizer with desolvation for AFS, but were significantly higher than those obtained by using the Baird spectrometer with a mini-monochromator and a ultrasonic nebulzer system.

India-EU relations in health services: prospects and challenges

PubMed Central

2011-01-01

Background India and the EU are currently negotiating a Trade and Investment Agreement which also covers services. This paper examines the opportunities for and constraints to India-EU relations in health services in the context of this agreement, focusing on the EU as a market for India's health services exports and collaboration. The paper provides an overview of key features of health services in the EU and India and their bearing on bilateral relations in this sector. Methods Twenty six semi-structured, in-person, and telephonic interviews were conducted in 2007-2008 in four Indian cities. The respondents included management and practitioners in a variety of healthcare establishments, health sector representatives in Indian industry associations, health sector officials in the Indian government, and official representatives of selected EU countries and the European Commission based in New Delhi. Secondary sources were used to supplement and corroborate these findings. Results The interviews revealed that India-EU relations in health services are currently very limited. However, several opportunity segments exist, namely: (i) Telemedicine; (ii) Clinical trials and research in India for EU-based pharmaceutical companies; (iii) Medical transcriptions and back office support; (iv) Medical value travel; and (v) Collaborative ventures in medical education, research, training, staff deployment, and product development. However, various factors constrain India's exports to the EU. These include data protection regulations; recognition requirements; insurance portability restrictions; discriminatory conditions; and cultural, social, and perception-related barriers. The interviews also revealed several constraints in the Indian health care sector, including disparity in domestic standards and training, absence of clear guidelines and procedures, and inadequate infrastructure. Conclusions The paper concludes that although there are several promising areas for India-EU relations in health services, it will be difficult to realize these opportunities given the pre-dominance of public healthcare delivery in the EU and sensitivities associated with commercializing healthcare. Hence, a gradual approach based on pilot initiatives and selective collaboration would be advisable initially, which could be expanded once there is demonstrated evidence on outcomes. Overall, the paper makes a contribution to the social science and health literature by adding to the limited primary evidence base on globalization and health, especially from a developing-developed country and regional perspective. PMID:21310041

Statistics of Scientific Procedures on Living Animals 2014: A new format, and hopefully a new era of diminishing animal experimentation?

PubMed

Hudson-Shore, Michelle

2016-03-01

The Annual Statistics of Scientific Procedures on Living Animals Great Britain 2014 reports a welcome decline in animal experimentation in the UK. However, caution has to be exercised when interpreting these most recent figures, due to the significant changes made to satisfy the requirements of Directive 2010/63/EU as to what information is reported and how it is reported. Comparisons to the figures and trends reported in previous years is difficult, so this paper focuses on the specifics of the current report, providing information on overall animal use and highlighting specific issues associated with genetically-altered animals, fish and primates. There is a detailed discussion of the extent of the changes, commenting on the benefits and disadvantages of the new format, in areas such as severity of procedures, legislation and techniques of special interest. It also considers the consequences of the changes on the effective monitoring of laboratory animal use, the openness and transparency regarding the impacts of animal use, and the implementation of Three Rs initiatives. In addition, suggestions for further improvements to the new format are made to the Home Office. 2016 FRAME.

[Building and implementation of management system in laboratories of the National Institute of Hygiene].

PubMed

Rozbicka, Beata; Brulińska-Ostrowska, Elzbieta

2008-01-01

The rules of good laboratory practice have always been observed in the laboratories of National Institute of Hygiene (NIH) and the reliability of the results has been carefully cared after when performing tests for clients. In 2003 the laboratories performing analyses related to food safety were designated as the national reference laboratories. This, added to the necessity of compliance with work standards and requirements of EU legislation and to the need of confirmation of competence by an independent organisation, led to a decision to seek accreditation of Polish Centre of Accreditation (PCA). The following stages of building and implementation of management system were presented: training, modifications of Institute's organisational structure, elaboration of management system's documentation, renovation and refurbishment of laboratory facilities, implementation of measuring and test equipment's supervision, internal audits and management review. The importance of earlier experiences and achievements with regard to validation of analytical methods and guarding of the quality of the results through organisation and participation in proficiency tests was highlighted. Current status of accreditation of testing procedures used in NIH laboratories that perform analyses in the field of chemistry, microbiology, radiobiology and medical diagnostic tests was presented.

Spanish experience on the design of radon surveys based on the use of geogenic information.

PubMed

Sainz Fernández, C; Quindós Poncela, L S; Fernández Villar, A; Fuente Merino, I; Gutierrez-Villanueva, J L; Celaya González, S; Quindós López, L; Quindós López, J; Fernández, E; Remondo Tejerina, J; Martín Matarranz, J L; García Talavera, M

2017-01-01

One of the requirements of the recently approved EU-BSS (European Basic Safety Standards Directive, EURATOM, 2013) is the design and implementation of national radon action plans in the member states (Annex XVIII). Such plans require radon surveys. The analysis of indoor radon data is supported by the existing knowledge about geogenic radiation. With this aim, we used the terrestrial gamma dose rate data from the MARNA project. In addition, we considered other criterion regarding the surface of Spain, population, permeability of rocks, uranium and radium contain in soils because currently no data are available related to soil radon gas concentration and permeability in Spain. Given that, a Spanish radon map was produced which will be part of the European Indoor Radon Map and a component of the European Atlas of Natural Radiation. The map indicates geographical areas with high probability of finding high indoor radon concentrations. This information will support legislation regarding prevention of radon entry both in dwellings and workplaces. In addition, the map will serve as a tool for the development of strategies at all levels: individual dwellings, local, regional and national administration. Copyright © 2016 Elsevier Ltd. All rights reserved.

Testing nano-silver food packaging to evaluate silver migration and food spoilage bacteria on chicken meat.

PubMed

Gallocchio, Federica; Cibin, Veronica; Biancotto, Giancarlo; Roccato, Anna; Muzzolon, Orietta; Carmen, Losasso; Simone, Belluco; Manodori, Laura; Fabrizi, Alberto; Patuzzi, Ilaria; Ricci, Antonia

2016-06-01

Migration of nanomaterials from food containers into food is a matter of concern because of the potential risk for exposed consumers. The aims of this study were to evaluate silver migration from a commercially available food packaging containing silver nanoparticles into a real food matrix (chicken meat) under plausible domestic storage conditions and to test the contribution of such packaging to limit food spoilage bacteria proliferation. Chemical analysis revealed the absence of silver in chicken meatballs under the experimental conditions in compliance with current European Union legislation, which establishes a maximum level of 0.010 mg kg(-1) for the migration of non-authorised substances through a functional barrier (Commission Regulation (EU) No. 10/2011). On the other hand, microbiological tests (total microbial count, Pseudomonas spp. and Enterobacteriaceae) showed no relevant difference in the tested bacteria levels between meatballs stored in silver-nanoparticle plastic bags or control bags. This study shows the importance of testing food packaging not only to verify potential silver migration as an indicator of potential nanoparticle migration, but also to evaluate the benefits in terms of food preservation so as to avoid unjustified usage of silver nanoparticles and possible negative impacts on the environment.

European nitrogen policies, nitrate in rivers and the use of the INCA model

NASA Astrophysics Data System (ADS)

Skeffington, R.

This paper is concerned with nitrogen inputs to European catchments, how they are likely to change in future, and the implications for the INCA model. National N budgets show that the fifteen countries currently in the European Union (the EU-15 countries) probably have positive N balances - that is, N inputs exceed outputs. The major sources are atmospheric deposition, fertilisers and animal feed, the relative importance of which varies between countries. The magnitude of the fluxes which determine the transport and retention of N in catchments is also very variable in both space and time. The most important of these fluxes are parameterised directly or indirectly in the INCA Model, though it is doubtful whether the present version of the model is flexible enough to encompass short-term (daily) variations in inputs or longer-term (decadal) changes in soil parameters. As an aid to predicting future changes in deposition, international legislation relating to atmospheric N inputs and nitrate in rivers is reviewed briefly. Atmospheric N deposition and fertiliser use are likely to decrease over the next 10 years, but probably not sufficiently to balance national N budgets.

The pros and cons of human therapeutic cloning in the public debate.

PubMed

Nippert, Irmgard

2002-09-11

Few issues linked to genetic research have raised as much controversial debate as the use of somatic cell nuclear transfer technology to create embryos specifically for stem cell research. Whereas European countries unanimously agree that reproductive cloning should be prohibited there is no agreement to be found on whether or not research into therapeutic cloning should be permitted. Since the UK took the lead and voted in favour of regulations allowing therapeutic cloning the public debate has intensified on the Continent. This debate reflects the wide spectrum of diverse religious and secular moralities that are prevalent in modern multicultural European democratic societies. Arguments range from putting forward strictly utilitarian views that weight the moral issues involved against the potential benefits that embryonic stem cell research may harbour to considering the embryo as a human being, endowed with human dignity and human rights from the moment of its creation, concluding that its use for research is unethical and should be strictly prohibited. Given the current state of dissension among the various European states, it is difficult to predict whether 'non-harmonisation' will prevail or whether in the long run 'harmonisation' of legislation that will allow stem cell research will evolve in the EU.

Simulated effect of pig-population density on epidemic size and choice of control strategy for classical swine fever epidemics in The Netherlands.

PubMed

Mangen, M-J J; Nielen, M; Burrell, A M

2002-12-18

We examined the importance of pig-population density in the area of an outbreak of classical swine fever (CSF) for the spread of the infection and the choice of control measures. A spatial, stochastic, dynamic epidemiological simulation model linked to a sector-level market-and-trade model for The Netherlands were used. Outbreaks in sparsely and densely populated areas were compared under four different control strategies and with two alternative trade assumptions. The obligatory control strategy required by current EU legislation was predicted to be enough to eradicate an epidemic starting in an area with sparse pig population. By contrast, additional control measures would be necessary if the outbreak began in an area with high pig density. The economic consequences of using preventive slaughter rather than emergency vaccination as an additional control measure depended strongly on the reactions of trading partners. Reducing the number of animal movements significantly reduced the size and length of epidemics in areas with high pig density. The phenomenon of carrier piglets was included in the model with realistic probabilities of infection by this route, but it made a negligible contribution to the spread of the infection.

Legacy of a Chemical Factory Site: Contaminated Groundwater Impacts Stream Macroinvertebrates.

PubMed

Rasmussen, Jes J; McKnight, Ursula S; Sonne, Anne Th; Wiberg-Larsen, Peter; Bjerg, Poul L

2016-02-01

Legislative and managing entities of EU member states face a comprehensive task because the chemical and ecological impacts of contaminated sites on surface waters must be assessed. The ecological assessment is further complicated by the low availability or, in some cases, absence of ecotoxicity data for many of the compounds occurring at contaminated sites. We studied the potential impact of a contaminated site, characterised by chlorinated solvents, sulfonamides, and barbiturates, on benthic macroinvertebrates in a receiving stream. Most of these compounds are characterised by low or unknown ecotoxicity, but they are continuously discharged into the stream by way of a long-lasting source generating long-term chronic exposure of the stream biota. Our results show that taxonomical density and diversity of especially sediment dwelling taxa were reduced by >50 % at the sampling sites situated in the primary inflow zone of the contaminated GW. Moreover, macroinvertebrate communities at these sampling sites could be distinguished from those at upstream control sites and sites situated along a downstream dilution gradient using multidimensional scaling. Importantly, macroinvertebrate indices currently used did not identify this impairment, thus underpinning an urgent need for developing suitable tools for the assessment of ecological effects of contaminated sites in streams.

Current Situation of Mycotoxin Contamination and Co-occurrence in Animal Feed—Focus on Europe

PubMed Central

Streit, Elisabeth; Schatzmayr, Gerd; Tassis, Panagiotis; Tzika, Eleni; Marin, Daniela; Taranu, Ionelia; Tabuc, Cristina; Nicolau, Anca; Aprodu, Iuliana; Puel, Olivier; Oswald, Isabelle P.

2012-01-01

Mycotoxins are secondary metabolites produced by fungi especially those belonging to the genus Aspergillus, Penicillum and Fusarium. Mycotoxin contamination can occur in all agricultural commodities in the field and/or during storage, if conditions are favourable to fungal growth. Regarding animal feed, five mycotoxins (aflatoxins, deoxynivalenol, zearalenone, fumonisins and ochratoxin A) are covered by EU legislation (regulation or recommendation). Transgressions of these limits are rarely observed in official monitoring programs. However, low level contamination by Fusarium toxins is very common (e.g., deoxynivalenol (DON) is typically found in more than 50% of the samples) and co-contamination is frequently observed. Multi-mycotoxin studies reported 75%–100% of the samples to contain more than one mycotoxin which could impact animal health at already low doses. Co-occurrence of mycotoxins is likely to arise for at least three different reasons (i) most fungi are able to simultaneously produce a number of mycotoxins, (ii) commodities can be contaminated by several fungi, and (iii) completed feed is made from various commodities. In the present paper, we reviewed the data published since 2004 concerning the contamination of animal feed with single or combinations of mycotoxins and highlighted the occurrence of these co-contaminations. PMID:23162698

Testing rank-dependent utility theory for health outcomes.

PubMed

Oliver, Adam

2003-10-01

Systematic violations of expected utility theory (EU) have been reported in the context of both money and health outcomes. Rank-dependent utility theory (RDU) is currently the most popular and influential alternative theory of choice under circumstances of risk. This paper reports a test of the descriptive performance of RDU compared to EU in the context of health. When one of the options is certain, violations of EU that can be explained by RDU are found. When both options are risky, no evidence that RDU is a descriptive improvement over EU is found, though this finding may be due to the low power of the tests. Copyright 2002 John Wiley & Sons, Ltd.

Potential for Introduction of Bat-Borne Zoonotic Viruses into the EU: A Review

PubMed Central

Simons, Robin R. L.; Gale, Paul; Horigan, Verity; Snary, Emma L.; Breed, Andrew C.

2014-01-01

Bat-borne viruses can pose a serious threat to human health, with examples including Nipah virus (NiV) in Bangladesh and Malaysia, and Marburg virus (MARV) in Africa. To date, significant human outbreaks of such viruses have not been reported in the European Union (EU). However, EU countries have strong historical links with many of the countries where NiV and MARV are present and a corresponding high volume of commercial trade and human travel, which poses a potential risk of introduction of these viruses into the EU. In assessing the risks of introduction of these bat-borne zoonotic viruses to the EU, it is important to consider the location and range of bat species known to be susceptible to infection, together with the virus prevalence, seasonality of viral pulses, duration of infection and titre of virus in different bat tissues. In this paper, we review the current scientific knowledge of all these factors, in relation to the introduction of NiV and MARV into the EU. PMID:24841385

Enhancing the Photovoltaic Performance of Perovskite Solar Cells with a Down-Conversion Eu-Complex.

PubMed

Jiang, Ling; Chen, Wangchao; Zheng, Jiawei; Zhu, Liangzheng; Mo, Li'e; Li, Zhaoqian; Hu, Linhua; Hayat, Tasawar; Alsaedi, Ahmed; Zhang, Changneng; Dai, Songyuan

2017-08-16

Organometal halide perovskite solar cells (PSCs) have shown high photovoltaic performance but poor utilization of ultraviolet (UV) irradiation. Lanthanide complexes have a wide absorption range in the UV region and they can down-convert the absorbed UV light into visible light, which provides a possibility for PSCs to utilize UV light for higher photocurrent, efficiency, and stability. In this study, we use a transparent luminescent down-converting layer (LDL) of Eu-4,7-diphenyl-1,10-phenanthroline (Eu-complex) to improve the light utilization efficiency of PSCs. Compared with the uncoated PSC, the PSC coated with Eu-complex LDL on the reverse of the fluorine-doped tin oxide glass displayed an enhancement of 11.8% in short-circuit current density (J sc ) and 15.3% in efficiency due to the Eu-complex LDL re-emitting UV light (300-380 nm) in the visible range. It is indicated that the Eu-complex LDL plays the role of enhancing the power conversion efficiency as well as reducing UV degradation for PSCs.

A project to establish a skills competency matrix for EU nurses.

PubMed

Cowan, David T; Norman, Ian J; Coopamah, Vinoda P

Enhanced nurse workforce mobility in the European Union (EU) is seen as a remedy to shortages of nurses in some EU countries and a surplus in others. However, knowledge of differences in competence, culture, skill levels and working practices of nursing staff throughout EU countries is not fully documented because currently no tangible method exists to enable comparison. The European Healthcare Training and Accreditation Network (EHTAN) project intends to address this problem by establishing an assessment and evaluation methodology through the compilation of a skills competency matrix. To this end, subsequent to a review of documentation and literature on nursing competence definition and assessment, two versions of a nursing competence self-assessment questionnaire tool have been developed. The final competence matrix will be translated and disseminated for transnational use and it is hoped that this will inform EU and national policies on the training requirements of nurses and nursing mobility and facilitate the promotion of EU-wide recognition of nursing qualifications.

Assessment of HIV molecular surveillance capacity in the European Union, 2016.

PubMed

Keating, Patrick; Pharris, Anastasia; Leitmeyer, Katrin; De Angelis, Stefania; Wensing, Annemarie; Amato-Gauci, Andrew J; Broberg, Eeva

2017-12-01

IntroductionExpanding access to HIV antiretroviral treatment is expected to decrease HIV incidence and acquired immunodeficiency syndrome (AIDS) mortality. However, this may also result in increased HIV drug resistance (DR). Better monitoring and surveillance of HIV DR is required to inform treatment regimens and maintain the long term effectiveness of antiretroviral drugs. As there is currently no formal European Union (EU)-wide collection of HIV DR data, this study aimed to assess the current HIV molecular surveillance capacity in EU/European Economic Area (EEA) countries in order to inform the planning of HIV DR monitoring at EU level. Methods: Thirty EU/EEA countries were invited to participate in a survey on HIV molecular surveillance capacity, which also included laboratory aspects. Results: Among 21 responding countries, 13 reported using HIV sequence data (subtype and/or DR) for surveillance purposes at national level. Of those, nine stated that clinical, epidemiological and sequence data were routinely linked for analysis. Discussion/conclusion : We identified similarities between existing HIV molecular surveillance systems, but also found important challenges including human resources, data ownership and legal issues that would need to be addressed.Information on capacities should allow better planning of the phased introduction of HIV DR surveillance at EU/EEA level.

Animal experimentation.

PubMed

Kolar, Roman

2006-01-01

Millions of animals are used every year in often times extremely painful and distressing scientific procedures. Legislation of animal experimentation in modern societies is based on the supposition that this is ethically acceptable when certain more or less defined formal (e.g. logistical, technical) demands and ethical principles are met. The main parameters in this context correspond to the "3Rs" concept as defined by Russel and Burch in 1959, i.e. that all efforts to replace, reduce and refine experiments must be undertaken. The licensing of animal experiments normally requires an ethical evaluation process, often times undertaken by ethics committees. The serious problems in putting this idea into practice include inter alia unclear conditions and standards for ethical decisions, insufficient management of experiments undertaken for specific (e.g. regulatory) purposes, and conflicts of interest of ethics committees' members. There is an ongoing societal debate about ethical issues of animal use in science. Existing EU legislation on animal experimentation for cosmetics testing is an example of both the public will for setting clear limits to animal experiments and the need to further critically examine other fields and aspects of animal experimentation.

Development of an online SPE-UHPLC-MS/MS method for the multiresidue analysis of the 17 compounds from the EU "Watch list".

PubMed

Gusmaroli, Lucia; Insa, Sara; Petrovic, Mira

2018-04-24

During the last decades, the quality of aquatic ecosystems has been threatened by increasing levels of pollutions, caused by the discharge of man-made chemicals, both via accidental release of pollutants as well as a consequence of the constant outflow of inadequately treated wastewater effluents. For this reason, the European Union is updating its legislations with the aim of limiting the release of emerging contaminants. The Commission Implementing Decision (EU) 2015/495 published in March 2015 drafts a "Watch list" of compounds to be monitored Europe-wide. In this study, a methodology based on online solid-phase extraction (SPE) ultra-high-performance liquid chromatography coupled to a triple-quadrupole mass spectrometer (UHPLC-MS/MS) was developed for the simultaneous determination of the 17 compounds listed therein. The proposed method offers advantages over already available methods, such as versatility (all 17 compounds can be analyzed simultaneously), shorter time required for analysis, robustness, and sensitivity. The employment of online sample preparation minimized sample manipulation and reduced dramatically the sample volume needed and time required, dramatically the sample volume needed and time required, thus making the analysis fast and reliable. The method was successfully validated in surface water and influent and effluent wastewater. Limits of detection ranged from sub- to low-nanogram per liter levels, in compliance with the EU limits, with the only exception of EE2. Graphical abstract Schematic of the workflow for the analysis of the Watch list compounds.

Cross-border care and healthcare quality improvement in Europe: the MARQuIS research project

PubMed Central

Suñol, R; Garel, P; Jacquerye, A

2009-01-01

Citizens are increasingly crossing borders within the European Union (EU). Europeans have always been free to travel to receive care abroad, but if they wished to benefit from their statutory social protection scheme, they were subject to their local or national legislation on social protection. This changed in 1991 with the European Court of Justice defining healthcare as a service, starting a debate on the right balance between different principles in European treaties: movement of persons, goods and services, versus the responsibility of member states to organise their healthcare systems. Simultaneously, cross-border cooperation has developed between member states. In this context, patient mobility has become a relevant issue on the EU’s agenda. The EU funded a number of Scientific Support to Policies (SSP) activities within the Sixth Framework Programme, to provide the evidence needed by EU policy makers to deal with issues that European citizens face due to enhanced mobility in Europe. One SSP project “Methods of Assessing Response to Quality Improvement Strategies” (MARQuIS), focused on cross-border care. It aimed to assess the value of different quality strategies, and to provide information needed when: (1) countries contract care for patients moving across borders; and (2) individual hospitals review the design of their quality strategies. This article describes the European context related to healthcare, and its implications for cross-border healthcare in Europe. The background information demonstrates a need for further research and development in this area. PMID:19188459

Alaska State Legislature

Science.gov Websites

The Alaska State Legislature search menu Home Senate Current Members Past Members By Session search Home Get Started About the Legislative Branch Legislative Branch The Legislative Branch is responsible for enacting the laws of the State of Alaska and appropriating the money necessary to operate the

Elementary Teacher Candidates' Understanding of the No Child Left Behind Legislation

ERIC Educational Resources Information Center

Reeder, Stacy; Utley, Juliana

2008-01-01

Within the next decade teacher preparation programs will be replete with teacher candidates who have experienced the implementation of the No Child Left Behind legislation in their K-12 schooling experience. However, most current teacher candidates graduated from their K-12 schooling experience before the legislation was implemented in schools.…

Comparison of legislation, regulations and national health strategies for palliative care in seven European countries (Results from the Europall Research Group): a descriptive study

PubMed Central

2013-01-01

Background According to EU policy, anyone in need of palliative care should be able to have access to it. It is therefore important to investigate which palliative care topics are subject to legislation and regulations in Europe and how these are implemented in (national) health care plans. This paper aims to deliver a structured overview of the legislation, existing regulations and the different health care policies regarding palliative care in seven European countries. Methods In 2008 an inventory of the organisation of palliative care was developed by the researchers of the Europall project. Included were two open questions about legislation, regulations, and health policy in palliative care. This questionnaire was completed using palliative care experts selected from Belgium, England, France, Germany, the Netherlands, Poland and Spain. Additionally, (grey) literature on palliative care health policy and regulations from the participating countries was collected to complete the inventory. Comparative analysis of country specific information was performed afterwards. Results In all countries palliative care regulations and policies existed (either in laws, royal decrees, or national policies). An explicit right to palliative care was mentioned in the Belgium, French and German law. In addition, access to palliative care was mentioned by all countries, varying from explicit regulations to policy intentions in national plans. Also, all countries had a national policy on palliative care, although sometimes mainly related to national cancer plans. Differences existed in policy regarding palliative care leave, advance directives, national funding, palliative care training, research, opioids and the role of volunteers. Conclusions Although all included European countries have policies on palliative care, countries largely differ in the presence of legislation and regulations on palliative care as well as the included topics. European healthcare policy recommendations should support palliative care access across Europe. PMID:23866928

Future development of global regulations of Chinese herbal products.

PubMed

Fan, Tai-Ping; Deal, Greer; Koo, Hoi-Lun; Rees, Daryl; Sun, He; Chen, Shaw; Dou, Jin-Hui; Makarov, Valery G; Pozharitskaya, Olga N; Shikov, Alexander N; Kim, Yeong Shik; Huang, Yi-Tsau; Chang, Yuan Shiun; Jia, William; Dias, Alberto; Wong, Vivian Chi-Woon; Chan, Kelvin

2012-04-10

GP-TCM is the first EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. One of the key deliverables of the Work Package 7 in GP-TCM was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies. The paper aims to collate data and draw comparison of these regulations. Case studies are also presented to illustrate the problems involved in registering TCM products in different regions worldwide. A collaborative network task force was established during the early stage of the GP-TCM project and operated through exchanges, teleconferences and focused discussions at annual meetings. The task force involved coordinators, academics who are actively involved with R&D of Chinese herbal medicines, experts on monographic standards of Chinese materia medica, representatives from regulatory agencies, experts from industries in marketing Chinese medicines/herbal medicines and natural products. The co-ordinators took turns to chair teleconferences, led discussions on specific issues at AGM discussion sessions, at joint workshops with other work-packages such as WP1 (quality issues), WP3 (toxicology issues) and WP6 (clinical trial issues). Collectively the authors were responsible for collating discussion outcomes and updating written information. A global overview of regulations on herbal registration has been compiled during the three years of the consortium. The regulatory requirements for registration of herbal products in the EU and China were compared, and this is extended to other regions/countries: Africa, Australia, Brazil, Canada, Japan, Russia, South Korea, Taiwan, and the United States. A wide variation of the regulations for the categories of herbal products exists: food (functional food, novel foods, dietary food for special medical purpose, foods for particular nutritional use, food supplement); cosmetic, traditional herbal medicine products; herbal medicines for human use and veterinary use. The regulatory issues for registration of herbal products are complicated among the countries and regions worldwide. The information summarised in the text is for reference only. Some regulations which are presented in this review are still in legislation process and may change in due course. Before taking any regulatory action, readers are advised to consult current official legislation and guidance and/or to seek appropriate professional advice. The lessons learnt from global regulation of TCM will provide valuable insights for regulation of other traditional medicine such as Ayurveda and Unani medicine, as well as other forms of indigenous medicine. The WHO is well placed to co-ordinate a consultation process with the aim of putting forward suggestions for harmonisation to key regulatory agencies. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Emission of biocides from hospitals: comparing current survey results with European Union default values.

PubMed

Tluczkiewicz, Inga; Bitsch, Annette; Hahn, Stefan; Hahn, Torsten

2010-04-01

Under the European Union (EU) Biocidal Products Directive 98/8/EC, comprehensive evaluations on substances of the Third Priority List were conducted until 31 July 2007. This list includes, among other categories, disinfectants for human hygiene (e.g., skin and surface disinfection). For environmental exposure assessment of biocides, the EU emission scenarios apply. Currently available default values for disinfectants are based on consumption data from not more than 8 hospitals and were originally assembled for other purposes. To revalidate these default values, a survey on annual consumption data was performed in 27 German hospitals. These data were analyzed to provide consumption data per bed and day and per nurse and day for particular categories of active ingredients and were compared with default values from the EU emission scenario documents. Although several deviations were detected, an overall acceptable correspondence between Emission Scenario Documents default values and the current survey data was found. (c) 2009 SETAC

New GMO regulations for old: Determining a new future for EU crop biotechnology

PubMed Central

2017-01-01

ABSTRACT In this review, current EU GMO regulations are subjected to a point-by point analysis to determine their suitability for agriculture in modern Europe. Our analysis concerns present GMO regulations as well as suggestions for possible new regulations for genome editing and New Breeding Techniques (for which no regulations presently exist). Firstly, the present GMO regulations stem from the early days of recombinant DNA and are not adapted to current scientific understanding on this subject. Scientific understanding of GMOs has changed and these regulations are now, not only unfit for their original purpose, but, the purpose itself is now no longer scientifically valid. Indeed, they defy scientific, economic, and even common, sense. A major EU regulatory preconception is that GM crops are basically different from their parent crops. Thus, the EU regulations are “process based” regulations that discriminate against GMOs simply because they are GMOs. However current scientific evidence shows a blending of classical crops and their GMO counterparts with no clear demarcation line between them. Canada has a “product based” approach and determines the safety of each new crop variety independently of the process used to obtain it. We advise that the EC re-writes it outdated regulations and moves toward such a product based approach.  Secondly, over the last few years new genomic editing techniques (sometimes called New Breeding Techniques) have evolved. These techniques are basically mutagenesis techniques that can generate genomic diversity and have vast potential for crop improvement. They are not GMO based techniques (any more than mutagenesis is a GMO technique), since in many cases no new DNA is introduced. Thus they cannot simply be lumped together with GMOs (as many anti-GMO NGOs would prefer). The EU currently has no regulations to cover these new techniques. In this review, we make suggestions as to how these new gene edited crops may be regulated. The EU is at a turning point where the wrong decision could destroy European agricultural competitively for decades to come. PMID:28278120

EuFishBioMed (COST Action BM0804): A European Network to Promote the Use of Small Fishes in Biomedical Research

PubMed Central

Bally-Cuif, Laure; Kelsh, Robert; Beis, Dimitris; Mione, Marina; Panula, Pertti; Figueras, Antonio; Gothilf, Yoav; Brösamle, Christian; Geisler, Robert; Knedlitschek, Gudrun

2012-01-01

Abstract Small fresh water fishes such as the zebrafish (Danio rerio) have become important model organisms for biomedical research. They currently represent the best vertebrate embryo models in which it is possible to derive quantitative data on gene expression, signaling events, and cell behavior in real time in the living animal. Relevant phenotypes in fish mutants are similar to those of other vertebrate models and human diseases. They can be analyzed in great detail and much faster than in mammals. In recent years, approximately 2500 genetically distinct fish lines have been generated by European research groups alone. Their potential, including their possible use by industry, is far from being exploited. To promote zebrafish research in Europe, EuFishBioMed was founded and won support by the EU COST programme (http://www.cost.esf.org/). The main objective of EuFishBioMed is to establish a platform of knowledge exchange for research on small fish models with a strong focus on widening its biomedical applications and an integration of European research efforts and resources. EuFishBioMed currently lists more than 300 member laboratories in Europe, offers funding for short-term laboratory visits, organizes and co-sponsors meetings and workshops, and has successfully lobbied for the establishment of a European Zebrafish Resource Centre. To maintain this network in the future, beyond the funding period of the COST Action, we are currently establishing the European Society for Fish Models in Biology and Medicine. PMID:22537014

The impact of European legislative and technology measures to reduce air pollutants on air quality, human health and climate

NASA Astrophysics Data System (ADS)

Turnock, S. T.; Butt, E. W.; Richardson, T. B.; Mann, G. W.; Reddington, C. L.; Forster, P. M.; Haywood, J.; Crippa, M.; Janssens-Maenhout, G.; Johnson, C. E.; Bellouin, N.; Carslaw, K. S.; Spracklen, D. V.

2016-02-01

European air quality legislation has reduced emissions of air pollutants across Europe since the 1970s, affecting air quality, human health and regional climate. We used a coupled composition-climate model to simulate the impacts of European air quality legislation and technology measures implemented between 1970 and 2010. We contrast simulations using two emission scenarios; one with actual emissions in 2010 and the other with emissions that would have occurred in 2010 in the absence of technological improvements and end-of-pipe treatment measures in the energy, industrial and road transport sectors. European emissions of sulphur dioxide, black carbon (BC) and organic carbon in 2010 are 53%, 59% and 32% lower respectively compared to emissions that would have occurred in 2010 in the absence of legislative and technology measures. These emission reductions decreased simulated European annual mean concentrations of fine particulate matter (PM2.5) by 35%, sulphate by 44%, BC by 56% and particulate organic matter by 23%. The reduction in PM2.5 concentrations is calculated to have prevented 80 000 (37 000-116 000, at 95% confidence intervals) premature deaths annually across the European Union, resulting in a perceived financial benefit to society of US232 billion annually (1.4% of 2010 EU GDP). The reduction in aerosol concentrations due to legislative and technology measures caused a positive change in the aerosol radiative effect at the top of atmosphere, reduced atmospheric absorption and also increased the amount of solar radiation incident at the surface over Europe. We used an energy budget approximation to estimate that these changes in the radiative balance have increased European annual mean surface temperatures and precipitation by 0.45 ± 0.11 °C and by 13 ± 0.8 mm yr-1 respectively. Our results show that the implementation of European legislation and technological improvements to reduce the emission of air pollutants has improved air quality and human health over Europe, as well as having an unintended impact on the regional radiative balance and climate.

Pan-European E-Government Services Architecture

NASA Astrophysics Data System (ADS)

Vitvar, Tomáš; Mocan, Adrian; Nazir, Sanaullah; Wang, Xia

E-Government has been the center of interest for public administrations, citizens and businesses, as well as software vendors for several years. E-Government enables customers and members of the public and private sectors to take advantage of automated administration processes accessible on-line. These activities involve electronic exchange of information to acquire or provide products or services, to place or receive orders, or to complete financial transactions. All such communications must be performed securely, while at the same time maintaining the privacy of involved parties. E-Government allows citizens and businesses to process requests on-line, and with minimal physical interactions with public bodies. Since a complex information support often needs to be developed incrementally, e-Government services were first available as single services in specific sectors and for specific users. While these services are being further developed and expanded to be available in more sectors and for more users, their growing number leads to requirements of total or partial automation of certain tasks, for example, discovery, selection, composition and mediation of services. In addition, extensive numbers of such services are available in different sectors, and their provisioning in complex scenarios requires a good information strategy along with a good architectural and technological basis. The main goal is to identify and define methods, standards, technologies as well as legislation to be used within the whole development process and provisioning of complex e-Government systems. In the EU, the e-Government information strategy can be seen at two levels as (1) a European strategy driven by the European Commission to enable e-Government services across the EU member states and (2) national strategies to form a national e-Government available within a particular EU member state. The initiative which aims to develop the European strategy at the EU level is called IDABC.1 Based on the fundamental principles of the EU, the goal of IDABC is to promote development and integration of EU sector systems (e.g. transport, health), to develop on-line front-office services, and most importantly to develop a European E-Government Framework. The purpose of this framework is to define methods, standards and technologies to enable seamless integration of e-Government services on a Europe-wide scale.

Bridgman Growth of Large SrI2:Eu2+ Single Crystals: A High-performance Scintillator for Radiation Detection Applications

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boatner, Lynn A; Ramey, Joanne Oxendine; Kolopus, James A

2013-01-01

Single-crystal strontium iodide (SrI2) doped with relatively high levels (e.g., 3 - 6 %) of Eu2+ exhibits characteristics that make this material superior, in a number of respects, to other scintillators that are currently used for radiation detection. Specifically, SrI2:Eu2+ has a light yield that is significantly higher than LaBr3:Ce3+ -a currently employed commercial high-performance scintillator. Additionally, SrI2:Eu2+ is characterized by an energy resolution as high as 2.6% at the 137Cs gamma-ray energy of 662 keV, and there is no radioactive component in SrI2:Eu2+ - unlike LaBr3:Ce3+ that contains 138La. The Ce3+-doped LaBr3 decay time is, however, faster (30 nsec)more » than the 1.2 sec decay time of SrI2:Eu2+. Due to the relatively low melting point of strontium iodide (~515 oC), crystal growth can be carried out in quartz crucibles by the vertical Bridgman technique. Materials-processing and crystal-growth techniques that are specific to the Bridgman growth of europium-doped strontium iodide scintillators are described here. These techniques include the use of a porous quartz frit to physically filter the molten salt from a quartz antechamber into the Bridgman growth crucible and the use of a bent or bulb grain selector design to suppress multiple grain growth. Single crystals of SrI2:Eu2+ scintillators with good optical quality and scintillation characteristics have been grown in sizes up to 5.0 cm in diameter by applying these techniques. Other aspects of the SrI2:Eu2+ crystal-growth methods and of the still unresolved crystal-growth issues are described here.« less

Is tuberculosis crossing borders at the Eastern boundary of the European Union?

PubMed Central

van der Werf, Marieke J.; Hollo, Vahur; Noori, Teymur

2013-01-01

Background: The Eastern border of the European Union (EU) consists of 10 countries after the expansion of the EU in 2004 and 2007. These 10 countries border to the East to countries with high tuberculosis (TB) notification rates. We analyzed the notification data of Europe to quantify the impact of cross-border TB at the Eastern border of the EU. Methods: We used TB surveillance data of 2010 submitted by 53 European Region countries to the European Centre for Disease Prevention and Control and the World Health Organization Regional Office for Europe. Notified TB cases were stratified by origin of the case (national/foreign). We calculated the contribution of foreign to overall TB notification. Results: In the 10 EU countries located at the EU Eastern border, 618 notified TB cases (1.7% of all notified TB cases) were of foreign origin. Of those 618 TB cases, 173 (28.0%) were from countries bordering the EU to the East. More specifically, 90 (52.0%) were from Russia, 33 (19.1%) from Belarus, 33 (19.1%) from Ukraine, 13 (7.5%) from Moldova and 4 (2.3%) from Turkey. Conclusions: Currently, migrants contribute little to TB notifications in the 10 EU countries at the Eastern border of the EU, but changes in migration patterns may result in an increasing contribution. Therefore, EU countries at the Eastern border of the EU should strive to provide prompt diagnostic services and adequate treatment of migrants. PMID:23813718

Interaction between Eu(III) and graphene oxide nanosheets investigated by batch and extended X-ray absorption fine structure spectroscopy and by modeling techniques.

PubMed

Sun, Yubing; Wang, Qi; Chen, Changlun; Tan, Xiaoli; Wang, Xiangke

2012-06-05

The interaction mechanism between Eu(III) and graphene oxide nanosheets (GONS) was investigated by batch and extended X-ray absorption fine structure (EXAFS) spectroscopy and by modeling techniques. The effects of pH, ionic strength, and temperature on Eu(III) adsorption on GONS were evaluated. The results indicated that ionic strength had no effect on Eu(III) adsorption on GONS. The maximum adsorption capacity of Eu(III) on GONS at pH 6.0 and T = 298 K was calculated to be 175.44 mg·g(-1), much higher than any currently reported. The thermodynamic parameters calculated from temperature-dependent adsorption isotherms suggested that Eu(III) adsorption on GONS was an endothermic and spontaneous process. Results of EXAFS spectral analysis indicated that Eu(III) was bound to ∼6-7 O atoms at a bond distance of ∼2.44 Å in the first coordination shell. The value of Eu-C bond distance confirmed the formation of inner-sphere surface complexes on GONS. Surface complexation modeling gave an excellent fit with the predominant mononuclear monodentate >SOEu(2+) and binuclear bidentate (>SO)(2)Eu(2)(OH)(2)(2+) complexes. This paper highlights the application of GONS as a suitable material for the preconcentration and removal of trivalent lanthanides and actinides from aqueous solutions in environmental pollution management.

Effect of silver ions and clusters on the luminescence properties of Eu-doped borate glasses

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jiao, Qing, E-mail: jiaoqing@nbu.edu.cn; Wang, Xi; Qiu, Jianbei

2015-12-15

Highlights: • Ag{sup +} and Ag clusters are investigated in the borate glasses via ion exchange method. • The aggregation of silver ions to the clusters was controlled by the ion exchange concentration. • Eu{sup 3+}/Eu{sup 2+} ions emission was enhanced with the sensitization of the silver species. • Energy transfer process from Ag ions and Ag clusters to Eu ions is identified by the lifetime measurements. - Abstract: Silver ions and clusters were applied to Eu{sup 3+}-doped borate glasses via the Ag{sup +}–Na{sup +} ion exchange method. Eu{sup 3+}/Eu{sup 2+} ion luminescence enhancement was achieved after silver ion exchange.more » Absorption spectra showed no band at 420 nm, which indicates that silver nanoparticles can be excluded as a silver state in the glass. Silver ion aggregation into clusters during the ion exchange process may be inferred. The effect of silver ions and clusters on rare earth emissions was investigated using spectral information and lifetime measurements. Significant luminescence enhancements were observed from the energy transfer of Ag{sup +} ions and clusters to Eu{sup 3+}/Eu{sup 2+} ions, companied with the silver ions aggregated into the clusters state. The results of this research may extend the current understanding of interactions between rare-earth ions and Ag species.« less

Challenges of Adolescent Psychology in the European Identity Context

ERIC Educational Resources Information Center

Lannegrand-Willems, Lyda; Barbot, Baptiste

2015-01-01

In Europe, the question of identity and youth civic engagement constitutes a challenge both for the European Union (EU) and for research on adolescent psychology. In this article, we discuss the European historical context and the current initiatives from the EU that aim to encourage civic engagement among young people. Then, we suggest some…

Multiculturalism Is D(r)ead in Europe

ERIC Educational Resources Information Center

Bajrektarevic, Anis

2014-01-01

There is a claim currently circulating the European Union (EU), both cynical and misleading: "multiculturalism is dead in Europe". No wonder, as the conglomerate of nation-states/EU has silently handed over one of its most important debates--that of European identity--to the left and right wing parties, recently followed by several…

Government capacities and stakeholders: what facilitates ehealth legislation?

PubMed Central

2014-01-01

Background Newly established high-technology areas such as eHealth require regulations regarding the interoperability of health information infrastructures and data protection. It is argued that government capacities as well as the extent to which public and private organizations participate in policy-making determine the level of eHealth legislation. Both explanatory factors are influenced by international organizations that provide knowledge transfer and encourage private actor participation. Methods Data analysis is based on the Global Observatory for eHealth - ATLAS eHealth country profiles which summarizes eHealth policies in 114 countries. Data analysis was carried out using two-component hurdle models with a truncated Poisson model for positive counts and a hurdle component model with a binomial distribution for zero or greater counts. Results The analysis reveals that the participation of private organizations such as donors has negative effects on the level of eHealth legislation. The impact of public-private partnerships (PPPs) depends on the degree of government capacities already available and on democratic regimes. Democracies are more responsive to these new regulatory demands than autocracies. Democracies find it easier to transfer knowledge out of PPPs than autocracies. Government capacities increase the knowledge transfer effect of PPPs, thus leading to more eHealth legislation. Conclusions All international regimes – the WHO, the EU, and the OECD – promote PPPs in order to ensure the construction of a national eHealth infrastructure. This paper shows that the development of government capacities in the eHealth domain has to be given a higher priority than the establishment of PPPs, since the existence of some (initial) capacities is the sine qua non of further capacity building. PMID:24410989

The role of the legislative and regulatory branches in promoting the use of geothermal energy in Latvia

NASA Astrophysics Data System (ADS)

Skapare, I.; Kreslins, A.; Cers, A.

2016-09-01

Latvia currently is self-sufficient in energy resources up to approximately 35 %. Annual fossil energy prices rise and risks of security of energy supply promote the development legislation in the matter of renewable resources. One of the Latvian Ministry of Economics' recent products is a new draft law called the "Renewable Energy Law", which has been created due to one of the European Union and Latvian national energy policy objectives: to increase the share of renewable energy up to 40 % by 2020 (Moore and Vanags, 2012). Currently, geothermal energy potential is assessed at 1 × 1013 kWh; nevertheless, it is difficult for geothermal energy to compete with other renewable energy resources in the Latvian energy market. A great job has been done in recent years at the legislative branch to choose the right methods for supporting the use of renewable energy resources. This paper aims is analysis of current situation and assessment of Latvian legislation possibilities to promote the use of geothermal energy.

Observation of unusual critical region behavior in the magnetic susceptibility of EuSe

NASA Astrophysics Data System (ADS)

Bykovetz, N.; Klein, J.; Lin, C. L.

2018-05-01

The Europium Chalcogenides (EuCh: EuO, EuS, EuSe, and EuTe) have been regarded as model examples of simple, cubic, Heisenberg exchange coupled magnetic systems, with a ferromagnetic nearest-neighbor exchange constant J1 and an antiferromagnetic next-nearest-neighbor constant J2. Unlike the other EuCh, EuSe exhibits a range of complex magnetic behaviors, the latter being attributed to EuSe being near the point where J2=-J1, where its magnetism appears to consist of nearly de-coupled 2D ferromagnetic sheets. Analysis of precision SQUID measurements of the magnetic susceptibility χ in EuSe showed that in the region from ˜Tc to ˜2Tc, a fit of the data to the critical equation χ = χ2Tc(T/Tc-1)-γ gives γ=2.0, an exponent not predicted by any current theory. Additionally, this fit predicts that Tc should be ˜0K. We tentatively interpret this by saying that in the paramagnetic region the system "thinks" EuSe should not order above T=0. Tc=0K is predicted by the Mermin-Wagner theorem (MW) for Heisenberg-coupled 2D magnetic systems, and we can show that when J2=-J1, MW can also be applied to the J1, J2 exchange model of the EuCh to give a rigorous Tc=0 prediction. Under 10 kbar applied pressure EuSe exhibits a different γ and fitted Tc. An additional, and rather strange, critical-region effect was discovered. The EuSe sample was found to exhibit a relaxation effect in a small range of temperatures, just above and just below the actual Tc of 4.7K, with time constants of up to 5 minutes. We cannot yet fully explain this observed macroscopic effect.

Building on the Foundations of Part C Legislation: Beginning the Conversation for Reauthorization

ERIC Educational Resources Information Center

Cole, Patricia; Oser, Cindy; Walsh, Sharon

2011-01-01

Just as the early years of a child's development create the architecture for future brain growth, early implementation of federal Part C legislation laid the groundwork for a system of supports for families of infants and toddlers with disabilities. Some aspects of the current legislation provide a sturdy foundation for sound policies and…

Current Status of Twice-Exceptional Students: A Look at Legislation and Policy in the United States

ERIC Educational Resources Information Center

Pereira, Nielsen; Knotts, J. Dusteen; Roberts, Julia Link

2015-01-01

Educational legislation and policy can lead to effective educational practices, especially for student populations that have had equal access to education addressing their needs, such as students with disabilities and gifted students. This study was an examination of state legislation and policy related to twice-exceptional learners in the United…

The Impact of Irish Policy and Legislation on How Adults with Learning Disabilities Make Choices

ERIC Educational Resources Information Center

Carey, Eileen; Griffiths, Colin

2016-01-01

This paper reflects the impact of policy and legislation in the context of how adults with learning disabilities make choices. Following an overview of policies which have improved choice for people with learning disability in the United Kingdom, this paper reviews "choice" in current Irish policy and legislation. This paper, while…

Investigation on the preparation and luminescence emission of LaF{sub 3}:Eu{sup 3+}@LaF{sub 3}/SiO{sub 2} core-shell nanostructure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shao, Jun, E-mail: jun-shao@snnu.edu.cn; Wang, Zhaojin; Wang, Ruibo

LaF{sub 3}:Eu{sup 3+}, LaF{sub 3}:Eu{sup 3+}@LaF{sub 3}, LaF{sub 3}:Eu{sup 3+}@CeF{sub 3} and LaF{sub 3}:Eu{sup 3+}@SiO{sub 2} nanoparticles were successfully synthesized via hydrothermal route and modified Stöber method. The surface property of LaF{sub 3}:Eu{sup 3+} particle was successfully modified by coating LaF{sub 3} and SiO{sub 2} shell onto the particle, which resulted in the change of the surface property and luminescence emission of LaF{sub 3}:Eu{sup 3+}. It was found that the surface quenchers were decreased and thus the nonradiative pathways were reduced with core/shell structure, which not only enhanced the yellow emission of the sample, but also changed the intensity ratiomore » of the yellow to orange emission. The dependence of the shell property and shell thickness on the luminescence emission spectra were investigated systematically. The current investigation can provide useful information for developing applications in biological imaging, detection, and sensing and other aspects.« less

EuCliD--a medical registry.

PubMed

Steil, H; Amato, C; Carioni, C; Kirchgessner, J; Marcelli, D; Mitteregger, A; Moscardo, V; Orlandini, G; Gatti, E

2004-01-01

The European Clinical Database EuCliD small star, filled has been developed as a tool for supervising selected quality indicators of about 200 European dialysis centers. Major efforts had to be made to comply with local and European laws regarding data security. EuCliD is a Lotus Notes based flat-file database currently containing medical data of more than 14,000 dialysis patients from 10 European countries. Another 15,000 patients from 150 centers in 4 South-American countries will be added soon. Data are entered either manually or by means of interfaces to existing local data managing systems. This information is transferred to a central Lotus Notes Server. Data evaluation was performed with statistical tools like SPSS. EuCliD is used as a part of the CQI (Continuous Quality Improvement) management system of Fresenius Medical Care (FMC) dialysis units. Each participating dialysis center receives (currently every half year) benchmarking reports at a regular interval. The benchmark for all quality parameters is the weighted mean of the corresponding data of all centers. An obvious impact of data sampling and data evaluation on the quality of the treatments could be observed within the first one and a half years of working with EuCliD. This also concerns important outcome predictors like Kt/V and hemoglobin concentration as the outcome itself expressed in hospitalization days and survival rates. With the help of EuCliD the user is able to sample clinical data, identify problems, search for solutions with the aim of improving the dialysis treatment quality and guarantee a high-class treatment quality for all patients.

Modeling nitrogen fluxes in Germany - where does the nitrogen go?

NASA Astrophysics Data System (ADS)

Klement, Laura; Bach, Martin; Breuer, Lutz

2016-04-01

According to the latest inventory of the EU Water Framework Directive, 26.3% of German groundwater bodies are in a poor chemical state regarding nitrate. Additionally, the EU initiated infringement proceedings against Germany for not meeting the quality standards of the EU Nitrate Directive. Agriculture has been determined as the main source of nitrate pollution due to over-fertilization and regionally high density of livestock farming. The nitrogen balance surplus is commonly used as an indicator characterizing the potential of nitrate leaching into groundwater bodies and thus also serves as a foundation to introduce legislative restrictions or to monitor the success of mitigation measures. Currently, there is an ongoing discussion which measures are suitable for reducing the risk of nitrate leaching and also to what extent. However, there is still uncertainty about just how much the nitrogen surplus has to be reduced to meet the groundwater quality standards nationwide. Therefore, the aims of our study were firstly to determine the level of the nitrogen surplus that would be acceptable at the utmost and secondly whether the currently discussed target value of 30 kg N per hectare agricultural land for the soil surface nitrogen balance would be sufficient. The models MONERIS (Modeling Nutrient Emissions in River System) and MoRE (Modelling of Regionalized Emissions), the latter based on the first, are commonly used for estimating nitrogen loads into the river system in Germany at the mesoscale, as well as the effect of mitigation measures in the context of the EU directive 2008/105/EC (Environmental quality standards applicable to surface water). We used MoRE to calculate nitrate concentration for 2759 analytical units in Germany. Main factors are the surplus of the soil surface nitrogen balance, the percolation rate and an exponent representing the denitrification in the vadose zone. The modeled groundwater nitrate concentrations did not correspond to the regional patterns of the groundwater bodies which fail the good WFD status, the N-surplus or the measured data. The parameters for denitrification and the percolation rate seemed to have a higher model sensitivity than the nitrogen surplus. MoRE was previously validated only for the total N load from groundwater into surface water but the modeling concept for nitrate concentration was seemingly never fitted to observed data and needs refinements. A literature research showed that no groundwater concentrations modeled with MoRE or MONERIS have been published for Germany until now. Instead, only the concentration in percolating water was shown - sometimes misleadingly labeled so that the reader could presume the map displayed groundwater concentrations. According to the MoRE approach, model parameters such as the percolation rate and denitrification intensity are more sensitive than the N surplus. The surplus can indicate only a potential leaching risk, while the actual threat varies substantially with regional soil and climate conditions. Consequently, the use of the nitrogen surplus as a sole indicator for nitrate leaching should be critically examined. For conception of nitrate reduction programs obviously the regionally varying site conditions cannot be disregarded.

Contingency planning for Phytophthora ramorum outbreaks: progress report work package 7, EU RAPRA project

Treesearch

M.H.C.G. Steeghs

2008-01-01

As part of the EU project ?Risk analysis for Phytophthora ramorum, a recently recognised pathogen threat to Europe and the cause of Sudden Oak Death in the USA? (acronym RAPRA) outbreak scenarios are defined and existing strategies for eradication and containment of Phytophthora ramorum evaluated. Based on the current knowledge...

Mediating Science and Society in the EU and UK: From Information-Transmission to Deliberative Democracy?

ERIC Educational Resources Information Center

Tlili, Anwar; Dawson, Emily

2010-01-01

In this paper we critically review recent developments in policies, practices and philosophies pertaining to the mediation between science and the public within the EU and the UK, focusing in particular on the current paradigm of Public Understanding of Science and Technology (PEST) which seeks to depart from the science information-transmission…

Competence-Based Blended Learning in Building Automation: Towards a EU Curriculum in "Domotica"

ERIC Educational Resources Information Center

Sommaruga, L.; De Angelis, E.

2007-01-01

A competence-based approach was applied to a blended learning on line distance training in the Euroinno EU project aimed at vocational training in building automation. The current paper describes the experience gathered during the learning process and the definition of the curriculum. A number of issues emerged during the sessions concerning…

Impact of Scotland's Smoke-Free Legislation on Pregnancy Complications: Retrospective Cohort Study

PubMed Central

Mackay, Daniel F.; Nelson, Scott M.; Haw, Sally J.; Pell, Jill P.

2012-01-01

Background Both active smoking and environmental tobacco smoke exposure are associated with pregnancy complications. In March 2006, Scotland implemented legislation prohibiting smoking in all wholly or partially enclosed public spaces. The aim of this study was to determine the impact of this legislation on preterm delivery and small for gestational age. Methods and Findings We conducted logistic regression analyses using national administrative pregnancy data covering the whole of Scotland. Of the two breakpoints tested, 1 January 2006 produced a better fit than the date when the legislation came into force (26 March 2006), suggesting an anticipatory effect. Among the 716,941 eligible women who conceived between August 1995 and February 2009 and subsequently delivered a live-born, singleton infant between 24 and 44 wk gestation, the prevalence of current smoking fell from 25.4% before legislation to 18.8% after legislation (p<0.001). Three months prior to the legislation, there were significant decreases in small for gestational age (−4.52%, 95% CI −8.28, −0.60, p = 0.024), overall preterm delivery (−11.72%, 95% CI −15.87, −7.35, p<0.001), and spontaneous preterm labour (−11.35%, 95% CI −17.20, −5.09, p = 0.001). In sub-group analyses, significant reductions were observed among both current and never smokers. Conclusions Reductions were observed in the risk of preterm delivery and small for gestational age 3 mo prior to the introduction of legislation, although the former reversed partially following the legislation. There is growing evidence of the potential for tobacco control legislation to have a positive impact on health. Please see later in the article for the Editors' Summary PMID:22412353

Europium-decorated graphene quantum dots as a fluorescent probe for label-free, rapid and sensitive detection of Cu(2+) and L-cysteine.

PubMed

Lin, Liping; Song, Xinhong; Chen, Yiying; Rong, Mingcong; Wang, Yiru; Zhao, Li; Zhao, Tingting; Chen, Xi

2015-09-03

In this work, europium-decorated graphene quantum dots (Eu-GQDs) were prepared by treating three-dimensional Eu-decorated graphene (3D Eu-graphene) via a strong acid treatment. Various characterizations revealed that Eu atoms were successfully complexed with the oxygen functional groups on the surface of graphene quantum dots (GQDs) with the atomic ratio of 2.54%. Compared with Eu free GQDs, the introduction of Eu atoms enhanced the electron density and improved the surface chemical activities of Eu-GQDs. Therefore, the obtained Eu-GQDs were used as a novel "off-on" fluorescent probe for the label-free determination of Cu(2+) and l-cysteine (L-Cys) with high sensitivity and selectivity. The fluorescence intensity of Eu-GQDs was quenched in the presence of Cu(2+) owing to the coordination reaction between Cu(2+) and carboxyl groups on the surface of the Eu-GQDs. The fluorescence intensity of Eu-GQDs recovered with the subsequent addition of L-Cys because of the strong affinity of Cu(2+) to L-Cys via the Cu-S bond. The experimental results showed that the fluorescence variation of the proposed approach had a good linear relationship in the range of 0.1-10 μM for Cu(2+) and 0.5-50 μM for L-Cys with corresponding detection limits of 0.056 μM for Cu(2+) and 0.31 μM for L-Cys. The current approach also displayed a special response to Cu(2+) and L-Cys over the other co-existing metal ions and amino acids, and the results obtained from buffer-diluted serum samples suggested its applicability in biological samples. Copyright © 2015 Elsevier B.V. All rights reserved.

Enhanced photoluminescence and thermal stability of divalent ions (Zn2+, Mg2+) assisted CaTiO3:Eu3+ perovskite phosphors for lighting applications

NASA Astrophysics Data System (ADS)

Singh, Dhananjay Kumar; Manam, J.

2018-03-01

Current study proposes the improved red emission of Zn2+ and Mg2+ ions incorporated CaTiO3:Eu3+ phosphors synthesized via the well-known solid-state reaction method. Under the 397 nm UV excitation, the Zn2+- and Mg2+-incorporated CaTiO3:0.15Eu3+ phosphor having orthorhombic structure with space group Pbnm exhibited an intense red emission at 619 nm. This can be credited to the hypersensitive 5D0 → 7F2 transition of Eu3+ ions, which is also indicative of the fact that the Eu3+ ions populated the non-inversion symmetry sites in the CaTiO3 lattices. The optimized composition CaTiO3:0.15Eu3+, 0.20Zn2+ and CaTiO3:0.15Eu3+, 0.10Mg2+ phosphors, pronounces in a magnificent enhancement of PL intensity by 5.5 and 2.5 times, respectively, as compared to CaTiO3:0.15 Eu3+ phosphor. From the temperature-dependent emission spectra, ΔEa were enunciated to be 0.101 and 0.086 eV for CaTiO3:0.15Eu3+, 0.20Zn2+ and CaTiO3:0.15Eu3+, 0.10Mg2+ phosphors, respectively, for thermal quenching. In addition, it can be better understood as related to the adequate thermal stability of 60% even at 450 and 420 K, respectively. Furthermore, the Judd-Ofelt theory was used to study the radiative intensity parameters of Eu3+ ions in the CaTiO3 lattices. The experimental results incited the bright prospects of synthesized ceramics as a promising candidate for lighting applications.

Cybersecurity: Current Legislation, Executive Branch Initiatives, and Options for Congress

DTIC Science & Technology

2009-09-30

responsibilities of cybersecurity stakeholders. Privacy and civil liberties—maintaining privacy and freedom of speech protections on the Internet...securing networks before tackling the attendant issues such as freedom of speech , privacy, and civil liberty protections as they pertain to the Internet...legislation to mandate privacy and freedom of speech protections to be incorporated into a national strategy. • Assessing current congressional

Implications of the accession of the Republic of Croatia to the European Union for Croatian health care system.

PubMed

Ostojić, Rajko; Bilas, Vlatka; Franc, Sanja

2012-09-01

The Republic of Croatia's accession to the European Union (EU) will affect all segments of economy and society, including the health care system. The aim of this paper is to establish the potential effects of joining the EU on Croatian health care, as well as to assess its readiness to enter this regional economic integration. The paper identifies potential areas of impact of EU accession on Croatian health care and analyzes the results of the conducted empirical research. In this research, a method of in-depth interviews was applied on a sample of 49 subjects; health professionals from public and private sectors, health insurance companies, pharmaceutical companies, drug wholesalers, and non-governmental organisations (patient associations). Once Croatia joins the EU, it will face: new rules and priorities in line with the current European health strategy; the possibilities of drawing funds from European cohesion funds; labour migrations; new guidelines on patient safety and mobility. From the aspect of harmonising national regulations with EU regulations in the area of health care, Croatian system can be assessed as ready to enter the EU. Croatia's accession to the EU can result in a better information flow, growth of competitiveness of Croatian health care system, enhanced quality, inflow of EU funds, development of health tourism, but also in increased migration of health care professionals, and potential increase in the cost of health care services. Functioning within the EU framework might result in adaptation to the EU standards, but it could also result in the concentration of staff and institutions in larger cities.

Mid-Term Assessment of the EU Drugs Strategy 2013-2020 and Final Evaluation of the Action Plan on Drugs 2013-2016: Final report.

PubMed

Emilie, Balbirnie; Matthew, Davies; Emma, Disley; Cristina Gonzalez, Monsalve; Stephen, Hartka; Stijn, Hoorens; Kristy, Kruithof; Martin, Sacher; Jirka, Taylor

2018-01-01

The aim of the EU Drugs Strategy 2013-2020 is to contribute to a reduction in drug demand and drug supply within the EU. The Strategy has so far been implemented by an Action Plan covering the period 2013-2016. This article sets out the findings of an evaluation that assesses the degree of implementation of the Strategy and the Action Plan in terms of outputs and, where possible, impacts. It looks at the extent to which the objectives of the Strategy have been achieved. The evaluation aims to provide evidence to support the European Commission's decision about whether to propose a new Action Plan for the period 2017-2020 and, if so, what changes would be needed compared to the current plan. Through applying a mixed-methods approach, the evaluation examined the effectiveness, efficiency, relevance and coherence of the actions undertaken on the basis of the EU Drugs Strategy and the Action Plan, as well as their EU added value. The evaluation makes 20 recommendations, addressed to the European Commission, Member States, the European Council and other stakeholders. The key recommendation for the Commission is that a new Action Plan should be implemented for the period 2017-2020. This should be an updated version of the current Action Plan, rather than taking a new approach or introducing more new actions.

Optical textile tests MRI patients from afar

NASA Astrophysics Data System (ADS)

Gould, Paula

2008-11-01

Researchers in Europe have developed a wearable textile fitted with optical sensors that could be used to remotely monitor a patient's breathing patterns while they undergo magnetic resonance imaging (MRI) scans. The new textile will allow medical staff to keep an eye on children and other vulnerable patients who often have to be calmed with sedatives or anaesthetic drugs to keep them still during a scan. The technique will be particularly useful if proposed European Union (EU) legislation that is designed to protect medical staff from being exposed to the high magnetic fields of MRI systems comes into force in 2012. The new rules would prevent nurses from being in the room where the scan is taking place.

Water Quality and Management Changes Over the History of Poland.

PubMed

Szalinska, Ewa

2018-01-01

Poland is one of the countries distinguished by a long and colorful past. Undergoing numerous turbulent socio-economic changes forced by the course of history, Poland is now one of the member states of the European Union. Experiencing low water quantity and high contamination levels in surface waters, Poland is following other EU countries in the effort to reach a "good" water status. Herein are presented impacts of changes in Polish history on water legislation, management, and research, as well as explanations for the perceptible split between engineering and scientific approaches to the aquatic issues. Drawbacks caused by unsatisfactory state research funding for the sciences and division of the water related contemporary scientific interests are also discussed.

PubMed

Pelizza, Paolo

2017-08-28

For a long time, European legislation has not considered the Obstructive Sleep Apnea Syndrome (OSAS) a relevant factor for road safety. In Italy, in 2010 the Scientific Society of Legal Medicine COMLAS published Guidelines for the assessment of fitness to drive. An entire chapter, written in collaboration with the Commission "Sleepiness, Safety and Transportation" of the Italian Association of Sleep Medicine (AIMS), is dedicated to the criteria for assessing fitness to drive of people with OSAS or narcolepsy. Only in 2016, following the adoption of European Commission Directive 2014/85/EU, Italian law recognized OSAS as a condition to be considered in the assessment of fitness to drive. The author discusses the ascertainment criteria and the medico-legal implications regarding information to patients and reporting duty.

A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial.

PubMed

Prescott, Eva; Meindersma, Esther P; van der Velde, Astrid E; Gonzalez-Juanatey, Jose R; Iliou, Marie Christine; Ardissino, Diego; Zoccai, Giuseppe Biondi; Zeymer, Uwe; Prins, Leonie F; Van't Hof, Arnoud Wj; Wilhelm, Matthias; de Kluiver, Ed P

2016-10-01

Cardiac rehabilitation (CR) is an evidence-based intervention to increase survival and quality of life. Yet studies consistently show that elderly patients are less frequently referred to CR, show less uptake and more often drop out of CR programmes. The European study on effectiveness and sustainability of current cardiac rehabilitation programmes in the elderly (EU-CaRE) project consists of an observational study and an open prospective, investigator-initiated multicentre randomised controlled trial (RCT) involving mobile telemonitoring guided CR (mCR). The aim of EU-CaRE is to map the efficiency of current CR of the elderly in Europe, and to investigate whether mCR is an effective alternative in terms of efficacy, adherence and sustainability. The EU-CaRE study includes patients aged 65 years or older with ischaemic heart disease or who have undergone heart valve surgery. A total of 1760 patients participating in existing CR programmes in eight regions of Europe will be included. Of patients declining regular CR, 238 will be included in the RCT and randomised in two study arms. The experimental group (mCR) will receive a personalised home-based programme while the control group will receive no advice or coaching throughout the study period. Outcomes will be assessed after the end of CR and at 12 months follow-up. The primary outcome is VO 2peak and secondary outcomes include variables describing CR uptake, adherence, efficacy and sustainability. The study will provide important information to improve CR in the elderly. The EU-CaRE RCT is the first European multicentre study of mCR as an alternative for elderly patients not attending usual CR. © The European Society of Cardiology 2016.

Update Money Management Units in Terms of New Legislation.

ERIC Educational Resources Information Center

Manzer, John P.

1981-01-01

Provides basic business teachers with a current analysis of the rapidly changing topic of financial institutions and related functions. Elements discussed include recent financial legislation and students' money management decisions. (CT)

Russian Language Testing and Integrated Examination for Foreign Citizens in Russia: Legislation Background and Legal Regulation Specific Features

ERIC Educational Resources Information Center

Dolzhikova, Anzhela

2015-01-01

The Russian Federation faces active law-making and legislative activities aimed at providing legal grounds for qualifying educational level of foreign nationals entering the country with the purpose to work and apply for citizenship. The article deals with the current legislation and regulations in their relationship with each other, their impact…

Luminescence properties and energy transfer of site-sensitive Ca(6-x-y)Mg(x-z)(PO(4))(4):Eu(y)(2+),Mn(z)(2+) phosphors and their application to near-UV LED-based white LEDs.

PubMed

Kwon, Ki Hyuk; Im, Won Bin; Jang, Ho Seong; Yoo, Hyoung Sun; Jeon, Duk Young

2009-12-21

On the basis of the structural information that the host material has excellent charge stabilization, blue-emitting Ca(6-x-y)Mg(x)(PO(4))(4):Eu(y)(2+) (CMP:Eu(2+)) phosphors were synthesized and systematically optimized, and their photoluminescence (PL) properties were evaluated. Depending upon the amount of Mg added, the emission efficiency of the phosphors could be enhanced. The substitution of Eu(2+) affected their maximum wavelength (lambda(max)) and thermal stability because the substitution site of Eu(2+) could be varied. To obtain single-phase two-color-emitting phosphors, we incorporated Mn(2+) into CMP:Eu(2+) phosphors. Weak red emission resulting from the forbidden transition of Mn(2+) could be enhanced by the energy transfer from Eu(2+) to Mn(2+) that occurs because of the spectral overlap between the photoluminescence excitation (PLE) spectrum of Mn(2+) and the PL spectrum of Eu(2+). The energy transfer process was confirmed by the luminescence spectra, energy transfer efficiency, and decay curve of the phosphors. Finally, the optimized Ca(6-x-y)Mg(x-z)(PO(4))(4):Eu(y)(2+),Mn(z)(2+) (CMP:Eu(2+),Mn(2+)) phosphors were applied with green emitting Ca(2)MgSi(2)O(7):Eu(2+) (CMS:Eu(2+)) phosphors to ultraviolet (UV) light emitting diode (LED)-pumped white LEDs. The CMS:Eu(2+)-mixed CMP:Eu(2+), Mn(2+)-based white LEDs showed an excellent color rendering index (CRI) of 98 because of the broader emission band and more stable color coordinates than those of commercial Y(3)Al(5)O(12):Ce(3+) (YAG:Ce(3+))-based white LEDs under a forward bias current of 20 mA. The fabricated white LEDs showed very bright natural white light that had the color coordinate of (0.3288, 0.3401), and thus CMP:Eu(2+),Mn(2+) could be regarded as a good candidate for UV LED-based white LEDs.

[Migrant vaccinations in Poland].

PubMed

Sakowski, Piotr

2012-01-01

After the European Union accession in 2004, Poland has been perceived by foreigners as an attractive destination of their migration, and also as a popular transit country for people going further to the Western Europe countries. The Nofer Institute of Occupational Medicine is involved in the implementation of the international project PROMOVAX (Promote Vaccinations among Migrant Populations in Europe). The objective of the project is to promote immunizations among migrant populations in Europe. This article presents the up-to-date legal regulations that are effective in Poland, taking into account their relevance to the issue of vaccinations in migrant population. The analysis of the Polish legislation concerning this problem shows that there are no specific regulations addressed to migrant population staying in our country. This issue seems to be popular in the European Union, where immunization of migrants is given high priority. From the point of view of health care professionals it is important to be aware of the fact that EU open borders favor the increased flow of people between countries. The scale of migration from outside the EU to its member states also contributes to the increase in potential contacts between health care workers and migrants working in Poland.

The Aspects About of Objectively Appraisals of Modeling Gypsum Quality and Composites of Phonic-Absorbent and Orthopedic on Base of Gypsum

NASA Astrophysics Data System (ADS)

Pop, P. A.; Ungur, P. A.; Lazar, L.; Marcu, F.

2009-11-01

The EU Norms about of protection environment, outside and inside ambient, and human health demands has lead at obtain of new materials on the base of airborne material, with high thermo and phonic-absorbent properties, porous and lightweight. The α and β-modeling gypsum plaster quality and lightweight depend on many factors as: fabrication process, granulation, roast temperature, work temperature, environment, additives used, breakage, etc. Also, the objectively appraisal of modeling gypsum quality depends of proper tests methods selection, which are legislated in norms, standards and recommendations. In Romanian Standards SR EN 13279-1/2005 and SR EN 13279-2/2005, adaptable from EU Norms EN 13279-1/2004 and EN 13279-2/2004, the characteristics gypsum family tests are well specification, as: granule-metric analysis, determination of water/plaster ratio, setting time, mechanical characteristics, adhesions and water restrain. For plaster with special use (phonic-absorbent and orthopedic materials, etc.) these determinations are not concluding, being necessary more parameters finding, as: elastic constant, phonic-absorbent coefficient, porosity, working, etc., which is imposed the completion of norms and standards with new determinations.

A case for increased private sector involvement in Ireland's national animal health services

PubMed Central

2008-01-01

Non-regulatory animal health issues, such as Johne's disease, infectious bovine rhinotracheitis (IBR) and mastitis will become increasing important, with ongoing globalisation of markets in animals and animal products. In response, Ireland may need to broaden the scope of its national animal health services. However, there have been concerns about the respective roles and responsibilities (both financial and otherwise) of government and industry in any such moves. This paper argues the case for increased private sector involvement in Ireland's national animal health services, based both on theoretical considerations and country case studies (the Netherlands and Australia). The Dutch and Australian case studies present examples of successful partnerships between government and industry, including systems and processes to address non-regulatory animal health issues. In each case, the roles and responsibilities of government are clear, as are the principles underpinning government involvement. Furthermore, the roles and responsibilities (financial and otherwise) of the Dutch and Australian industry are determined through enabling legislation, providing both legitimacy and accountability. There are constraints on the use of EU and national government funds to support non-regulatory animal health services in EU member states (such as Ireland and the Netherlands). PMID:21851708

Wet-weather urban discharges: implications from adopting the revised European Directive concerning the quality of bathing water.

PubMed

David, L M; Matos, J S

2005-01-01

Wet weather urban discharges are responsible for bathing water contamination. The proposal for a revised EU Directive concerning the quality of bathing water imposes significantly more stringent requirements for the management of bathing water quality, with particularly important repercussions on beaches subjected to short-term pollution incidents. The paper reviews the aspects from EU legislation most directly related to the problem of wet-weather discharges, placing special emphasis on the recent revision process of the Directive on bathing water quality, and evaluates the benefits of some potential solutions based on continuous modelling of a combined sewer system. Increasing the sewer system storage capacity or the STP hydraulic capacity may substantially reduce the untreated discharge volumes, but spill frequency reductions under 2 to 3 spill days per bathing season will hardly be achieved. Results show the severe strains that local rainfall patterns would place on compliance with the Commission's proposal for a revised Directive and highlight the importance of the changes introduced in the amended proposal recently approved by the Council, making it less prescriptive if adequate measures are adopted to prevent bathers' exposure to short-term pollution incidents.

Freedom and Security — Responses to the Threat of International Terrorism

NASA Astrophysics Data System (ADS)

Tinnefeld, Marie-Theres

The September 11 attacs have led to a number of changes in the legislative framework of the EU member states. Governments intended to react quickly, powerfully and with high public visibility reactions in public to justify the power of technology in the interests of national security. The new goal is to search terrorist activity in the ocean of telecommunications data retained by communications providers and accessed by intelligence authorities. EU member states have to put in place a national data retention law by March 2009. In Germany, the most recent problem is the question of the legality of the secret online-surveillance and search of IT-Sytems, especially concerning of individual’s PCs. The German Federal Constitutional Court has held, that the area of governmental authority for intervention must be limited by the constitutional protection of human dignity and fundamental rights like information privacy, telecommunications secrecy and respect for the home. In February 2008 the highest German Court created a new human right of confidentially and integrity of IT-Systems. The decision has to be understood as a reaction to the widespread use of invisible information technology by legal authorities and their secret and comprehensive surveillance of the citizens.

Causes of drug shortages in the legal pharmaceutical framework.

PubMed

De Weerdt, Elfi; Simoens, Steven; Hombroeckx, Luc; Casteels, Minne; Huys, Isabelle

2015-03-01

Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages. Different European and national legislations governing human medicinal products were analyzed (e.g. Directive 2001/83/EC and Directive 2011/62/EU), supplemented with literature studies. For patented drugs, external price referencing may encompass the largest impact on drug shortages. For generic medicines, internal or external reference pricing, tendering as well as price capping may affect drug shortages. Manufacturing/quality requirements also contribute to drug shortages, since non-compliance leads to recalls. The influence of parallel trade on drug shortages is still rather disputable. Price and quality regulations are both important causes of drug shortages or drug unavailability. It can be concluded that there is room for improvement in the pharmaceutical legal framework within the lines drawn by the EU to mitigate drug shortages. Copyright © 2015 Elsevier Inc. All rights reserved.

Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspective

PubMed Central

Auby, Philippe

2008-01-01

A large proportion of medicines used in children are prescribed off-label, and children have often been denied access to new or innovative medications. Because such situation is unethical, the need to obtain paediatric information for medicines used in children seems nowadays a matter of consensus on a global basis. Based on this, it was clear in EU, like what has happened in the US, that there was a need for a legal obligation for Pharmaceutical Companies to perform studies. This new European Paediatric Regulation that entered into force in 2007 opens a new era of European drug regulatory history and will offer a major opportunity to improve children's health through advancements in research by providing a new framework for evaluating the efficacy and safety of medicines for children. But, paediatric development remains challenging and the hurdles of conducting research in paediatric population are numerous. The article presents the new European Paediatric Regulation, illustrates its rationale through paediatric psychopharmacology, and discusses some of its consequences on paediatric research from an industry perspective. Recommendations for further international collaboration are also suggested to make global paediatric development plans. PMID:19063723

Characterization of suspected illegal skin whitening cosmetics.

PubMed

Desmedt, B; Van Hoeck, E; Rogiers, V; Courselle, P; De Beer, J O; De Paepe, K; Deconinck, E

2014-03-01

An important group of suspected illegal cosmetics consists of skin bleaching products, which are usually applied to the skin of the face, hands and décolleté for local depigmentation of hyper pigmented regions or more importantly, for a generalized reduction of the skin tone. These cosmetic products are suspected to contain illegal active substances that may provoke as well local as systemic toxic effects, being the reason for their banning from the EU market. In that respect, illegal and restricted substances in cosmetics, known to have bleaching properties, are in particular hydroquinone, tretinoin and corticosteroids. From a legislative point of view, all cosmetic products containing a prohibited whitening agent are illegal and must be taken off the EU market. A newly developed screening method using ultra high performance liquid chromatography-time off flight-mass spectrometry allows routine analysis of suspected products. 163 suspected skin whitening cosmetics, collected by Belgian inspectors at high risk sites such as airports and so-called ethnic cosmetic shops, were analyzed and 59% were classified as illegal. The whitening agents mostly detected were clobetasol propionate and hydroquinone, which represent a serious health risk when repeatedly and abundantly applied to the skin. Copyright © 2013 Elsevier B.V. All rights reserved.

Comparison of the availability of groundwater information sources in Poland with other European countries. Knowledge inventory for hydrogeology research - project KINDRA

NASA Astrophysics Data System (ADS)

Tomaszewska, Barbara; Dendys, Marta; Tyszer, Magdalena

2017-11-01

Regulations of the Water Framework Directive 200/60/EC (WFD) had been applied by European Union countries into their legislation system. However, it does not guarantee that the groundwater research has the same standard and quality in EU countries. KINDRA international research project was launched to assessment of existing groundwater-related practical and scientific knowledge based on a new Hydrogeological Research Classification System (HRC-SYS). This classification is supported by a web-service - the European Inventory of Groundwater Research (EIGR). The main goal of the project is implementation policy of optimization in groundwater research in EU. The preliminary result of survey about groundwater management shows that in Poland is a good state of implementation WFD. Good level of implementation is especially related with groundwater monitoring. It is because a lot of institutions and municipal entities carry out their tasks referring to quality or quantity assessment. Results of their works are published as reports, newsletters, maps, bulletins etc. These materials are potential source of information which can be a valuable contribution to EIGR. However, a lot of information are published only in polish language, so it is impossible to spread this knowledge in Europe.

Flexible work hours, health and well-being in the European Union: preliminary data from a SALTSA project.

PubMed

Costa, G; Akerstedt, T; Nachreiner, F; Baltieri, F; Folkard, S; Frings Dresen, M; Gadbois, C; Gartner, J; Grzech Sukalo, H; Harma, M; Kandolin, I; Silverio, J; Simoes, A

2001-12-01

Demand for flexible work hours (FWH) is increasing in Europe aimed at increasing the number of production hours on one hand, and, on the other, reducing individual working hours and/or increasing autonomy and control on them. In view of the lack of knowledge of the effects of FWH on health and safety, we started a pilot project, funded by the Joint Programme for Working Life Research in Europe (SALTSA), aimed at: a) comparing the most relevant national legislation and how the EU Directive 93/104 "concerning certain aspects of working time" has been implemented in the member States; b) reporting prevalence and trend of FWH in Europe according to the three EU Surveys on Working Conditions carried out in the last decade; c) collecting practical examples of innovative FWH; d) evaluating their impact on health and safety in relation to work sectors, job demands, social life, aging and gender. Consequent actions are going to include information and consultancy for pertinent authorities and social parties involved, as well as training programmes for Union officials and similar groups concerning the organisation of FWH according to ergonomic principles.

A case for increased private sector involvement in Ireland's national animal health services.

PubMed

More, Simon J

2008-02-01

Non-regulatory animal health issues, such as Johne's disease, infectious bovine rhinotracheitis (IBR) and mastitis will become increasing important, with ongoing globalisation of markets in animals and animal products. In response, Ireland may need to broaden the scope of its national animal health services. However, there have been concerns about the respective roles and responsibilities (both financial and otherwise) of government and industry in any such moves. This paper argues the case for increased private sector involvement in Ireland's national animal health services, based both on theoretical considerations and country case studies (the Netherlands and Australia). The Dutch and Australian case studies present examples of successful partnerships between government and industry, including systems and processes to address non-regulatory animal health issues. In each case, the roles and responsibilities of government are clear, as are the principles underpinning government involvement. Furthermore, the roles and responsibilities (financial and otherwise) of the Dutch and Australian industry are determined through enabling legislation, providing both legitimacy and accountability. There are constraints on the use of EU and national government funds to support non-regulatory animal health services in EU member states (such as Ireland and the Netherlands).

Testing of the Advanced Stirling Radioisotope Generator Engineering Unit at NASA Glenn Research Center

NASA Technical Reports Server (NTRS)

Lewandowski, Edward J.

2013-01-01

The Advanced Stirling Radioisotope Generator (ASRG) is a high-efficiency generator being developed for potential use on a Discovery 12 space mission. Lockheed Martin designed and fabricated the ASRG Engineering Unit (EU) under contract to the Department of Energy. This unit was delivered to NASA Glenn Research Center in 2008 and has been undergoing extended operation testing to generate long-term performance data for an integrated system. It has also been used for tests to characterize generator operation while varying control parameters and system inputs, both when controlled with an alternating current (AC) bus and with a digital controller. The ASRG EU currently has over 27,000 hours of operation. This paper summarizes all of the tests that have been conducted on the ASRG EU over the past 3 years and provides an overview of the test results and what was learned.

The EU environmental policy context for monitoring for and with raptors in Europe.

PubMed

Duke, Guy

2008-09-01

This paper outlines the importance of the policy context for monitoring with and for raptors, and, conversely, of the importance of such monitoring for policy. It then outlines two key areas of European Union (EU) environmental policy most relevant to monitoring for and with raptors, namely biodiversity policy and pollution policy. For each of the policy areas, the pertinent objectives and actions of the current EU policy are identified, and their relevance for raptor monitoring is discussed. The potential contribution of raptor monitoring to the further development of these policy areas is also addressed.

Electronic cigarette use in the European Union: analysis of a representative sample of 27 460 Europeans from 28 countries.

PubMed

Farsalinos, Konstantinos E; Poulas, Konstantinos; Voudris, Vassilis; Le Houezec, Jacques

2016-11-01

To assess prevalence of electronic cigarette (e-cigarette) use, reported changes in smoking status due to e-cigarette use and correlates of e-cigarette use in the European Union (EU) member states in 2014. Cross-sectional survey of EU citizens representative of the population (Special Eurobarometer 429). All 28 Member States of the EU. A total of 27 460 EU citizens aged ≥ 15 years (after excluding those who responded 'Do not know' to the questions about smoking status and e-cigarette use). Descriptive analysis [%, 95% confidence interval (CI)] of e-cigarette use prevalence (current use, past use and past experimentation) according to smoking status, self-reported changes in smoking status according to patterns of e-cigarette use and logistic regression analysis to examine correlates of e-cigarette use, especially socio-demographic factors and smoking status. Ever e-cigarette use was reported by 31.1% (95% CI = 30.0-32.2%) of current smokers, 10.8% (95% CI = 10.0-11.7%) of former smokers and 2.3% (95% CI = 2.1-2.6%) of never smokers. Past experimentation [7.2% (95% CI = 6.9-7.5%)] was more common than current [1.8% (95% CI = 1.6-1.9%)] and past use [2.6% (95% CI = 2.4-2.8%)]. Extrapolated to the whole population, approximately 48.5 million EU citizens were ever e-cigarette users, with 76.8% using nicotine-containing e-cigarettes. An estimated 6.1 and 9.2 million EU citizens had quit and reduced smoking with the help of e-cigarettes, respectively. Initiation with e-cigarettes was reported by 0.8% (95% CI = 0.6-0.9%) of participants who reported ever use of any tobacco-related product. Only 1.3% (95% CI = 1.1-1.5%) of never smokers used nicotine-containing e-cigarettes, with 0.09% (95% CI = 0.04-0.14%) reporting daily nicotine use. Smoking cessation with the help of e-cigarettes was reported by 35.1% (95% CI = 30.7-39.5%) of current e-cigarette users, while a further 32.2% (95% CI = 29.9-36.5%) reported smoking reduction. Being current [odds ratio (OR) = 21.23, 95% CI = 18.32-24.59) or former smokers (OR = 6.49, 95% CI = 5.49-7.67) were the strongest correlates of ever e-cigarette use. E-cigarette use in the European Union appears to be largely confined to current or former smokers, while current use and nicotine use by people who have never smoked is rare. More than one-third of current e-cigarette users polled reported smoking cessation and reduction. © 2016 Society for the Study of Addiction.

The impact of council directive 2011/70/EURATOM and IAEA joint convention review meetings on the ongoing establishment of the Portuguese regulatory framework and on the future of national radioactive waste

DOE Office of Scientific and Technical Information (OSTI.GOV)

Paiva, Isabel; Trindade, Romao B.

Council Directive 2011/70/EURATOM of 19 July 2011, establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste will enter in force August 2013 in all EU Member States. Portugal has already started preparing its legislative framework to accommodate the new legislative piece. However, the first report of Portugal to the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management of the IAEA, in Vienna, 2012, has shown that Portugal still has many steps to overcome to establish a successful and effective basic regulatory framework. The existencemore » of many competent authorities related to the radiological protection area and a newly independent commission that is still looking on how to fulfill its regulator role in other areas such as the radioactive waste management makes quite challenging the full application of the new directive as well as compliance that Portugal will have to show in the next Joint Convention review meeting in order to meet the obligations of the Convention. In this paper, the reality of the regulatory Portuguese framework on radiological protection, nuclear safety and radioactive waste management is presented. Discussion of the future impact of the new legislation and its consequences such as the need to setup the national program on radioactive waste management is critical discussed. (authors)« less

Sustainable use of veterinary pharmaceuticals on the territory (Sust-PHarm): Linking available database of manure management and environmental fate models.

PubMed

Di Guardo, Andrea; Finizio, Antonio

2017-01-01

Analogously to the evolution of the EU legislation on pesticides, there is an increasing need of strategies aiming to reach a "sustainable use of veterinary pharmaceuticals". To this end, it is essential to develop tools, such as supporting information systems (SIS), for managing the environmental risks of veterinary pharmaceuticals on a territorial scale. In this context, we propose Sust-PHarm (SUSTainable use of veterinary Pharmaceuticals), a SIS useful to identify groundwater vulnerable areas to veterinary pharmaceuticals at both local and regional scale. As background, Sust-PHarm follows the schemes of SIS for pesticides. The latter are based on the integration of predictive models in GIS. The proposed approach goes a step forward by integrating also data on the typologies of livestock farm, their spatial distribution and manure management techniques. This information allows to identify the potential environmental loads of veterinary pharmaceuticals. In this paper, we discuss the innovative elements characterizing Sust-PHarm through a comparison with the SIS currently used for pesticides. The advantages of Sust-PHarm are discussed using Lombardia Region (Northern Italy) as a case study. Simulations were made on 12 veterinary pharmaceuticals characterized by different physical-chemical properties. Results are compared with the current guidelines for the evaluation of veterinary pharmaceuticals leaching highlighting some substantial differences when realistic data are utilized making our approach more accurate than guidelines one. Copyright © 2016 Elsevier B.V. All rights reserved.

[Accidents and injuries in the EU. Results of the EuroSafe Reports].

PubMed

Bauer, R; Steiner, M; Kisser, R; Macey, S M; Thayer, D

2014-06-01

Accidents and injuries are a relevant although largely preventable public health problem. Information on the causes of accidents is the basis for accident prevention and product safety. The current report "Injuries in the European Union", edited by EuroSafe, the European Association for Injury Prevention and Safety Promotion, is a summary of key statistics on accidents and injuries at the EU level. In addition to international data on cause of death, the data of the European Injury Data Base (IDB) in particular are presented. The IDB is a unique data source for the EU based on an internationally standardized dataset of external causes and circumstances of injuries, which is collected in the emergency department of hospitals. Thus, the IDB covers the entire spectrum of accidents and injuries in sufficient detail as is necessary for the derivation of preventive measures and the knowledge of involved products. The currently available IDB data are collected by the participating Member States (2012: Austria, Cyprus, Denmark, Germany, Italy, Latvia, Malta, The Netherlands, Norway, Portugal, Slovenia, and Sweden) in self-interest (i.e., without legal obligation) with the support of the EU health programs. The central database for the IDB is run by the European Commission and provides public access to the aggregated data of the participating countries. Currently, over 100 IDB hospitals in the EU upload around 300,000 cases per year into the EU database. The IDB contains information on all accident sectors (transport, workplace, school etc.) with a focus on leisure and sports accidents. Depending on the accident sector, up to 25 variables (activities, products involved, means of transport etc.) and often also short narratives are recorded for each case. The report shows that 40 million people are treated in a hospital annually in the EU after accidents and violence, and that about 233,000 people die as a consequence of injury. There are large differences between countries in the rates of fatal and nonfatal injuries; these differences can be interpreted as a measure of the potential for prevention and as an indication of targeted measures in the countries with higher accident rates. The report also includes snapshots of the eight priority themes for injury prevention, as defined in the Recommendation of the European Council on Injury Prevention and Safety Promotion in 2007: children, adolescents and older people, vulnerable road users, sports, the use of products and services, violence, and self-injury. The implementation of the IDB has proven to be feasible and useful for the participating countries, especially for data-based accident prevention in the important areas of home, leisure, and sports accidents. In the framework of the EU project JAMIE (2011-2014, Joint Action for Injury Monitoring in Europe), the IDB partners are currently working on further improving the IDB standards and quality criteria as well as the recruitment of further IDB countries. The medium-term goal is to integrate the EU IDB in the Eurostat Statistical System and to put the collection of IDB data on a statutory footing.

Theory of Mind and Emotion Understanding Predict Moral Development in Early Childhood

ERIC Educational Resources Information Center

Lane, Jonathan D.; Wellman, Henry M.; Olson, Sheryl L.; LaBounty, Jennifer; Kerr, David C. R.

2010-01-01

The current study utilized longitudinal data to investigate how theory of mind (ToM) and emotion understanding (EU) concurrently and prospectively predicted young children's moral reasoning and decision making. One hundred twenty-eight children were assessed on measures of ToM and EU at 3.5 and 5.5 years of age. At 5.5 years, children were also…

Policy in Transition: The Emergence of Tackling Early School Leaving (ESL) as EU Policy Priority

ERIC Educational Resources Information Center

Gillies, Donald; Mifsud, Denise

2016-01-01

This paper explores, from a Foucauldian perspective, the emergence and nature of the current EU education policy priority issue of "early school leaving". The paper suggests that a number of problematisations developing from the failure to secure Lisbon Strategy objectives have served to create a much stronger focus on the issue of young…

The Road Travelled in Europe towards the 2020 European Objectives in Education. A Spanish Perspective

ERIC Educational Resources Information Center

Martínez Seijo, María Luz; Torrego Seijo, Juan Carlos

2016-01-01

From the beginning of the European Community to the current EU there have been important steps in education cooperation between the participating countries. In this article, we analyse the facts and difficulties that influence the educational policy of the EU to reach agreements and the facts that define common work until the year 2020, mainly…

Intrinsic radioactivity of KSr2I5:Eu2+

NASA Astrophysics Data System (ADS)

Rust, M.; Melcher, C.; Lukosi, E.

2016-10-01

A current need in nuclear security is an economical, yet high energy resolution (near 2%), scintillation detector suitable for gamma-ray spectroscopy. For current scintillators on the market, there is an inverse relationship between scintillator energy resolution and cost of production. A new promising scintillator, KSr2I5:Eu2+, under development at the University of Tennessee, has achieved an energy resolution of 2.4% at 662 keV at room temperature, with potential growth rates exceeding several millimeters per hour. However, the internal background due to the 40K content could present a hurdle for effective source detection/identification in nuclear security applications. As a first step in addressing this question, this paper reports on a computational investigation of the intrinsic differential pulse height spectrum (DPHS) generated by 40K within the KSr2I5:Eu2+ scintillator as a function of crystal geometry. It was found that the DPHS remains relatively equal to a constant multiplicative factor of the negatron emission spectrum with a direct increase of the 1.46 MeV photopeak relative height to the negatron spectrum with volume. Further, peak pileup does not readily manifest itself for practical KSr2I5:Eu2+ volumes.

Unpacking commercial sector opposition to European smoke-free policy: lack of unity, ‘fear of association’ and harm reduction debates

PubMed Central

Weishaar, Heide; Amos, Amanda; Collin, Jeff

2016-01-01

Objective Tobacco companies have made extensive efforts to build alliances against comprehensive smoke-free legislation. This article analyses the interaction between actors who opposed the development of the European Council Recommendation on smoke-free environments. Methods Drawing on data from 200 policy documents and 32 semistructured interviews and using qualitative textual analysis and organisational network analysis, opponents’ positions on, and responses to, the policy initiative, strategies to oppose the policy, and efforts to build alliances were investigated. Results The non-binding nature of the policy, scientific evidence and clear political will to adopt EU-wide measures combined to limit the intensity of commercial sector opposition to the comprehensive EU smoke-free policy. Most tobacco companies, led by the Confederation of European Community Cigarette Manufacturers (CECCM), voiced reservations against the proposal, criticised the policy process and fought flanking measures on product regulation. However, some companies focused on instigating harm reduction debates. These divergent approaches and the reluctance of other commercial actors to demonstrate solidarity with the tobacco sector prevented the establishment of a cohesive commercial sector alliance. Conclusions The comparatively limited opposition to EU smoke-free policy contrasts with previous accounts of tobacco industry resistance to tobacco control. While context-specific factors can partially explain these differences, the paper indicates that the sector's diminished credibility and lack of unity hampered political engagement and alliance building. Industry efforts to emphasise the benefits of smokeless tobacco during smoke-free policy debates highlight the potential of harm reduction as a gateway for tobacco companies to re-enter the political arena. PMID:26055268

Estimating greenhouse gas emissions of European cities--modeling emissions with only one spatial and one socioeconomic variable.

PubMed

Baur, Albert H; Lauf, Steffen; Förster, Michael; Kleinschmit, Birgit

2015-07-01

Substantive and concerted action is needed to mitigate climate change. However, international negotiations struggle to adopt ambitious legislation and to anticipate more climate-friendly developments. Thus, stronger actions are needed from other players. Cities, being greenhouse gas emission centers, play a key role in promoting the climate change mitigation movement by becoming hubs for smart and low-carbon lifestyles. In this context, a stronger linkage between greenhouse gas emissions and urban development and policy-making seems promising. Therefore, simple approaches are needed to objectively identify crucial emission drivers for deriving appropriate emission reduction strategies. In analyzing 44 European cities, the authors investigate possible socioeconomic and spatial determinants of urban greenhouse gas emissions. Multiple statistical analyses reveal that the average household size and the edge density of discontinuous dense urban fabric explain up to 86% of the total variance of greenhouse gas emissions of EU cities (when controlled for varying electricity carbon intensities). Finally, based on these findings, a multiple regression model is presented to determine greenhouse gas emissions. It is independently evaluated with ten further EU cities. The reliance on only two indicators shows that the model can be easily applied in addressing important greenhouse gas emission sources of European urbanites, when varying power generations are considered. This knowledge can help cities develop adequate climate change mitigation strategies and promote respective policies on the EU or the regional level. The results can further be used to derive first estimates of urban greenhouse gas emissions, if no other analyses are available. Copyright © 2015 Elsevier B.V. All rights reserved.

Structural precaution: the application of premarket approval schemes in EU food legislation.

PubMed

van der Meulen, Bernd M J; Bremmers, Harry J; Wijnands, Jo H M; Poppe, Krijn J

2012-01-01

Structural precaution refers to legal requirements by which food products (whether as ingredients, additives, genetically modified or innovative in some other form) are only admitted to the market after authorization by public authorities and till then are presumed unsafe. In the EU such authorization is granted after provision of conclusive scientific evidence of the product's safety by the applicant. The objective of this article is to critically evaluate structural precaution in the EU against the general principles of European and international law. Moreover, it addresses the positive and negative side-effects of structural precaution for food businesses. The methods which are applied are legal-systematic and empirical. Legal-systematic research shows that the European system of structural precaution may come into conflict with the principles of free trade. Empirical research on the effects of structural precaution shows that the barriers to market access impede food innovations, negatively impact competitiveness, and induce opportunistic strategic responses by food businesses. Among the opportunistic strategic responses that were identified are window-dressing, trespassing and circumventing. These may have adverse effects on food safety. This is remarkable since food safety is the key driving force behind the application of structural precaution. The article advocates an overhaul of the present European risk prevention framework. It argues that the newly proposed European legal framework for innovative foods only partly addresses the identified problems with which the food industry is confronted. Supplementary to legal-systematic overhaul, authorities should invest in accessibility and transparency of the legal framework and provide compliance assistance to reduce regulatory burdens.

Children with multiple sclerosis should not become therapeutic hostages

PubMed Central

Rose, Klaus; Müller, Thomas

2016-01-01

Background: Both the United States (US) Food and Drug Administration (FDA) and the European Union (EU) European Medicines Agency (EMA) order pediatric clinical trials as a condition for approval of new compounds. We evaluate clinical value and likelihood of sufficient recruitment for pediatric multiple sclerosis (pMS) studies and discuss US and EU pediatric legislation with pMS as a paradigm. Methods: We analyzed pMS clinical trials requested by the FDA and the EMA and industry-sponsored pMS studies registered on www.clinicaltrials.gov and www.clinicaltrialsregister.eu. Results: The FDA demands four and the EMA 15 pMS trials Conclusions: pMS is rare. Neither FDA nor EMA prioritize compounds for potential benefit in pMS. The EMA in particular orders multiple pMS studies, which will probably not recruit enough patients. Therefore, it is likely that the pMS trial outcomes will not be relevant for evidence-based medicine analyses, clinical practice and a pMS label for the respective drug. EMA requests for multiple pediatric studies have been described in metastasized adolescent melanoma, another very rare pediatric disease. The terms ‘ghost studies’ and ‘therapeutic hostages’ have been proposed for such trials and children whose parents are lured into permitting study participation. Clinical studies are not ethical if the probability is high that they will not provide reasonable outcomes. For now, pMS clinicians will have to continue to use new MS drugs in children off-label. They might consider a more proactive international coordinating role in prioritizing and testing new MS compounds in children. PMID:27582894

Colleges and universities sticking to their guns?

PubMed

Mendez, Jesse Perez; Sabina, Lou; Loffi, Jon

Firearm possession on college and university campuses remains a volatile public policy issue among policymakers, legislators, scholars, and administrators. Given the American federal governmental structure, many states have developed legislative approaches to "carry on campus" policies throughout the years that align with federal law. This study explores the diversity of state approaches and nuances of "carry on campus" throughout recent years and current state legislation under consideration. The implications of "carry on campus" legislation vary on college campuses, depending on applicable state law; however, some general dynamics apply to all.

Design of a Facility to Test the Advanced Stirling Radioisotope Generator Engineering Unit

NASA Technical Reports Server (NTRS)

Lewandowski, Edward J.; Schreiber, Jeffrey G.; Oriti, Salvatore M.; Meer, David W.; Brace, Michael H.; Dugala, Gina

2009-01-01

The Advanced Stirling Radioisotope Generator (ASRG) is being considered to power deep space missions. An engineering unit, the ASRG-EU, was designed and fabricated by Lockheed Martin under contract to the Department of Energy. This unit is currently on an extended operation test at NASA Glenn Research Center to generate performance data and validate the life and reliability predictions for the generator and the Stirling convertors. A special test facility was designed and built for testing the ASRG-EU. Details of the test facility design are discussed. The facility can operate the convertors under AC bus control or with the ASRG-EU controller. It can regulate input thermal power in either a fixed temperature or fixed power mode. An enclosure circulates cooled air around the ASRG-EU to remove heat rejected from the ASRG-EU by convection. A custom monitoring and data acquisition system supports the test. Various safety features, which allow 2417 unattended operation, are discussed.

Pharmacology and Therapeutics Education in the European Union Needs Harmonization and Modernization: A Cross‐sectional Survey Among 185 Medical Schools in 27 Countries

PubMed Central

Tichelaar, J; Okorie, M; Bissell, L; Christiaens, T; Likic, R; Mačìulaitis, R; Costa, J; Sanz, EJ; Tamba, BI; Maxwell, SR; Richir, MC; van Agtmael, MA

2017-01-01

Effective teaching in pharmacology and clinical pharmacology and therapeutics (CPT) is necessary to make medical students competent prescribers. However, the current structure, delivery, and assessment of CPT education in the European Union (EU) is unknown. We sent an online questionnaire to teachers with overall responsibility for CPT education in EU medical schools. Questions focused on undergraduate teaching and assessment of CPT, and students' preparedness for prescribing. In all, 185 medical schools (64%) from 27 EU countries responded. Traditional learning methods were mainly used. The majority of respondents did not provide students with the opportunity to practice real‐life prescribing and believed that their students were not well prepared for prescribing. There is a marked difference in the quality and quantity of CPT education within and between EU countries, suggesting that there is considerable scope for improvement. A collaborative approach should be adopted to harmonize and modernize the undergraduate CPT education across the EU. PMID:28295236

Dangerous Elements.

ERIC Educational Resources Information Center

Pinkham, Jim

1994-01-01

Discusses legislation currently under consideration that sets standards for the amount of radon, aluminum, and arsenic allowable in drinking water. Considers the economic impact of the legislation and traces the status of the Safe Drinking Water Act Regulations from 1989-92. (MDH)

Are chemicals in articles an obstacle for reaching environmental goals? - Missing links in EU chemical management.

PubMed

Molander, Linda; Breitholtz, Magnus; Andersson, Patrik L; Rybacka, Aleksandra; Rudén, Christina

2012-10-01

It is widely acknowledged that the management of risks associated with chemicals in articles needs to be improved. The EU environmental policy states that environmental damage should be rectified at source. It is therefore motivated that the risk management of substances in articles also takes particular consideration to those substances identified as posing a risk in different environmental compartments. The primary aim of the present study was to empirically analyze to what extent the regulation of chemicals in articles under REACH is coherent with the rules concerning chemicals in the Sewage Sludge Directive (SSD) and the Water Framework Directive (WFD). We also analyzed the chemical variation of the organic substances regulated under these legislations in relation to the most heavily used chemicals. The results show that 16 of 24 substances used in or potentially present in articles and regulated by the SSD or the WFD are also identified under REACH either as a substance of very high concern (SVHC) or subject to some restrictions. However, for these substances we conclude that there is limited coherence between the legislations, since the identification as an SVHC does not in itself encompass any use restrictions, and the restrictions in REACH are in many cases limited to a particular use, and thus all other uses are allowed. Only a minor part of chemicals in commerce is regulated and these show a chemical variation that deviates from classical legacy pollutants. This warrants new tools to identify potentially hazardous chemicals in articles. We also noted that chemicals monitored in the environment under the WFD deviate in their chemistry from the ones regulated by REACH. In summary, we argue that to obtain improved resource efficiency and a sustainable development it is necessary to minimize the input of chemicals identified as hazardous to health or the environment into articles. Copyright © 2012 Elsevier B.V. All rights reserved.

Open exchange of scientific knowledge and European copyright: The case of biodiversity information

PubMed Central

Egloff, Willi; Patterson, David J.; Agosti, Donat; Hagedorn, Gregor

2014-01-01

Abstract Background. The 7th Framework Programme for Research and Technological Development is helping the European Union to prepare for an integrative system for intelligent management of biodiversity knowledge. The infrastructure that is envisaged and that will be further developed within the Programme “Horizon 2020” aims to provide open and free access to taxonomic information to anyone with a requirement for biodiversity data, without the need for individual consent of other persons or institutions. Open and free access to information will foster the re-use and improve the quality of data, will accelerate research, and will promote new types of research. Progress towards the goal of free and open access to content is hampered by numerous technical, economic, sociological, legal, and other factors. The present article addresses barriers to the open exchange of biodiversity knowledge that arise from European laws, in particular European legislation on copyright and database protection rights. We present a legal point of view as to what will be needed to bring distributed information together and facilitate its re-use by data mining, integration into semantic knowledge systems, and similar techniques. We address exceptions and limitations of copyright or database protection within Europe, and we point to the importance of data use agreements. We illustrate how exceptions and limitations have been transformed into national legislations within some European states to create inconsistencies that impede access to biodiversity information. Conclusions. The legal situation within the EU is unsatisfactory because there are inconsistencies among states that hamper the deployment of an open biodiversity knowledge management system. Scientists within the EU who work with copyright protected works or with protected databases have to be aware of regulations that vary from country to country. This is a major stumbling block to international collaboration and is an impediment to the open exchange of biodiversity knowledge. Such differences should be removed by unifying exceptions and limitations for research purposes in a binding, Europe-wide regulation. PMID:25009418

Mitigating the effect of development on bats in England with derogation licensing.

PubMed

Stone, Emma Louise; Jones, Gareth; Harris, Stephen

2013-12-01

The Convention on Biological Diversity has catalyzed worldwide awareness of threats to biological diversity and stimulated global conservation strategies. These have led to national and international legislation and have generated debate about the most effective conservation actions. Under the EU Habitats Directive, all member states are obliged to establish a system for strict protection of species listed in Annex IV(a), which includes all bats. In England, this obligation has resulted in legislation that allows for derogation from strict protection under license, provided activities are undertaken to mitigate any potential negative effects on bat numbers. We used an evidence-based approach to assess the cost-effectiveness of mitigation strategies and the English bat-derogation licensing process as a whole. We analyzed data from 389 bat derogation licenses issued in England from 2003 to 2005 relating to 1776 roosts and 15 species to determine the nature and extent of development and mitigation activities and their effects on bats. Overall the effects of licensed activities on roosts were negative. Despite the level of protection afforded to bats, the majority (68%) of roosts for which derogation licenses were issued were destroyed. There were species-specific differences in the probability of roosts being destroyed, and impacts on roosts did not reflect a species' conservation status. Information provided by licensees was inadequate and inconsistent. Most licensees (67%) failed to submit postdevelopment reports, and postdevelopment monitoring was conducted at only 19% of sites. Despite a minimum of £4.13 million spent on mitigation structures for bats from 2003 to 2005, it was unclear whether the licensing process meets EU obligations. On the basis of our results, we believe there is a need to overhaul the licensing process, to establish a comprehensive, standardized postdevelopment monitoring system, and to demonstrate that mitigation is commensurate with Britain's legal obligations. Mitigando el Efecto del Desarrollo sobre los Murciélagos en Inglaterra con Licencias de Derogación. © 2013 Society for Conservation Biology.

Previous Open Rotor Research in the US

NASA Technical Reports Server (NTRS)

VanZante, Dale

2011-01-01

Previous Open Rotor noise experience in the United States, current Open Rotor noise research in the United States and current NASA prediction methods activities were presented at a European Union (EU) X-Noise seminar. The invited attendees from EU industries, research establishments and universities discussed prospects for reducing Open Rotor noise and reviewed all technology programs, past and present, dedicated to Open Rotor engine concepts. This workshop was particularly timely because the Committee on Aviation Environmental Protection (CAEP) plans to involve Independent Experts in late 2011 in assessing the noise of future low-carbon technologies including the open rotor.

Legislating for advocacy: The case of whistleblowing.

PubMed

Watson, Chanel L; O'Connor, Tom

2017-05-01

The role of nurses as patient advocates is one which is well recognised, supported and the subject of a broad body of literature. One of the key impediments to the role of the nurse as patient advocate is the lack of support and legislative frameworks. Within a broad range of activities constituting advocacy, whistleblowing is currently the subject of much discussion in the light of the Mid Staffordshire inquiry in the United Kingdom (UK) and other instances of patient mistreatment. As a result steps to amend existing whistleblowing legislation where it exists or introduce it where it does not are underway. This paper traces the development of legislation for advocacy. The authors argue that while any legislation supporting advocacy is welcome, legislation on its own will not encourage or enable nurses to whistleblow.

An analysis of physician antitrust exemption legislation: adjusting the balance of power.

PubMed

Hellinger, F J; Young, G J

2001-07-04

Current antitrust law restricts physicians from joining together to collectively negotiate. However, such activities may be approved by state laws under the so-called state action immunity doctrine and by federal legislation under an explicit antitrust exemption. In 1999, Texas became the first state to pass physician antitrust exemption legislation allowing physicians, under certain defined circumstances, to collectively negotiate fees with health plans. Last year, similar legislation was introduced in the US Congress, in 18 state legislatures, and in the District of Columbia. This legislation was passed only in the District of Columbia where its implementation was blocked by the city's financial control board. Nonetheless, legislation permitting physicians to collectively negotiate fees with managed care plans has been introduced in 10 state legislatures this year, and there is continued interest in introducing similar legislation in the US Congress. This analysis examines the basic features of this legislation and its potential impact on the balance of power between physicians and managed care plans.

Rethinking Sensitized Luminescence in Lanthanide Coordination Polymers and MOFs: Band Sensitization and Water Enhanced Eu Luminescence in [Ln(C15H9O5)3(H2O)3]n (Ln = Eu, Tb).

PubMed

Einkauf, Jeffrey D; Kelley, Tanya T; Chan, Benny C; de Lill, Daniel T

2016-08-15

A coordination polymer [Ln(C15H9O9)3(H2O)3]n (1-Ln = Eu(III), Tb(III)) assembled from benzophenonedicarboxylate was synthesized and characterized. The organic component is shown to sensitize lanthanide-based emission in both compounds, with quantum yields of 36% (Eu) and 6% (Tb). Luminescence of lanthanide coordination polymers is currently described from a molecular approach. This methodology fails to explain the luminescence of this system. It was found that the band structure of the organic component rather than the molecular triplet state was able to explain the observed luminescence. Deuterated (Ln(C15H9O9)3(D2O)3) and dehydrated (Ln(C15H9O9)3) analogues were also studied. When bound H2O was replaced by D2O, lifetime and emission increased as expected. Upon dehydration, lifetimes increased again, but emission of 1-Eu unexpectedly decreased. This reduction is reasoned through an unprecedented enhancement effect of the compound's luminescence by the OH/OD oscillators in the organic-to-Eu(III) energy transfer process.

Contamination versus preservation of cosmetics: a review on legislation, usage, infections, and contact allergy.

PubMed

Lundov, Michael Dyrgaard; Moesby, Lise; Zachariae, Claus; Johansen, Jeanne Duus

2009-02-01

Cosmetics with high water content are at a risk of being contaminated by micro-organisms that can alter the composition of the product or pose a health risk to the consumer. Pathogenic micro-organisms such as Staphylococcus aureus and Pseudomonas aeruginosa are frequently found in contaminated cosmetics. In order to avoid contamination of cosmetics, the manufacturers add preservatives to their products. In the EU and the USA, cosmetics are under legislation and all preservatives must be safety evaluated by committees. There are several different preservatives available but the cosmetic market is dominated by a few preservatives: parabens, formaldehyde, formaldehyde releasers, and methylchloroisothiazolinone/methylisothiazolinone. Allergy to preservatives is one of the main reasons for contact eczema caused by cosmetics. Concentration of the same preservative in similar products varies greatly, and this may indicate that some cosmetic products are over preserved. As development and elicitation of contact allergy is dose dependent, over preservation of cosmetics potentially leads to increased incidences of contact allergy. Very few studies have investigated the antimicrobial efficiency of preservatives in cosmetics, but the results indicate that efficient preservation is obtainable with concentrations well below the maximum allowed.

Dietary supplement intake during pregnancy; better safe than sorry?

PubMed

de Boer, Alie; Bast, Aalt; Godschalk, Roger

2018-06-01

Consumption of dietary supplements and specifically niche products such as supplements targeting pregnant women is increasing. The advantages of dietary supplementation during pregnancy with folic acid have been established, but health effects of many other supplements have not been confirmed. EU and US legislation on dietary supplements requires the product to be safe for the direct consumer, the mother. Long-term health effects for the fetus due to fetal programming (in utero adaptation of the fetal epigenome due to environmental stimuli such as supplementation) are not taken into account. Such epigenetic alterations can, however, influence the response to health challenges in adulthood. We therefore call for both conducting research in birth cohorts and animal studies to identify potential health effects in progeny of supplement consuming mothers as well as the establishment of a nutrivigilance scheme to identify favorable and adverse effects post-marketing. The acquired knowledge can be used to create more effective legislation on dietary supplement intake during pregnancy for safety of the child. Increasing knowledge on the effects of consuming supplements will create a safer environment for future mothers and their offspring to optimize their health before, during and after pregnancy. Copyright © 2018 Elsevier Inc. All rights reserved.

Longitudinal Impact of the Smoking Ban Legislation in Acute Coronary Syndrome Admissions.

PubMed

Abreu, D; Sousa, P; Matias-Dias, C; Pinto, F J

2017-01-01

Background and Purpose . The association between smoking and CV has been proved; however smoking is still the first preventable cause of death in the EU. We aim to evaluate the potential impact of the smoke ban on the number of ACS events in the Portuguese population. In addition, we evaluate the longitudinal effects of the smoking ban several years after its implementation. Methods . We analyzed the admission rate for ACS before and after the ban using data from hospital admission. Monthly crude rate was computed, using the Portuguese population as the denominator. Data concerning the proportion of smokers among ACS patients were obtained from the NRACS. Interrupted time series were used to assess changes over time. Results . A decline of -5.8% was found for ACS crude rate after the smoking ban. The decreasing trend was observed even after years since the law. The effect of the ban was higher in men and for people over 65 years. The most significant reduction of ACS rate was found in Lisbon. Conclusions . Our results suggest that smoking ban is related to a decline in ACS admissions, supporting the importance of smoke legislation as a public health measure, contributing to the reduction of ACS rate.

Current Chinese Leadership Travels Abroad, May 1984 - June 1986

DTIC Science & Technology

1986-06-01

Committee Gu Angran, Vice Chairman, National People’s Congress Legislative Affairs Commission Yang Jingyu , Deputy Secretary General, National People’s...Supreme People’s Court Hua Liankui, President, Shanghai People’s Higher Court 0 Tang Guangli, President, GuangCong People’s Higher Court 0 1.4 S...Legislative Affairs Commission Yang Jingyu , Deputy Secretary General, National People’s Congress Legislative Affairs Commission Liu Shuqing, Assistant

A Mixed Method Approach to Understanding Teacher Empowerment in Georgia Schools after Implementation of the No Child Left Behind Legislation

ERIC Educational Resources Information Center

Coble, Barbara S.

2010-01-01

The purpose of this study was to examine teachers' current and retrospective perceptions of empowerment within the context of the No Child Left Behind Legislation. Much of the empowerment research to date was conducted prior to the No Child Left Behind (NCLB) Act which was signed into law in January, 2002. The legislation mandates that K-12 public…

Measuring the Contribution of Higher Education to Innovation Capacity in the EU. Final Report: Revised Version

ERIC Educational Resources Information Center

European Commission, 2017

2017-01-01

This current study is part of the actions taken aiming to analyse the links between the operations and effects of higher-education institutions on the capacity to innovate in the economies in Europe. Providing insights into the contribution of higher education to the innovative capacity of the EU economies is crucial for policy making and the…

Measuring the Contribution of Higher Education to Innovation Capacity in the EU. Executive Summary of the Final Report

ERIC Educational Resources Information Center

European Commission, 2017

2017-01-01

This current study is part of the actions taken aiming to analyse the links between the operations and effects of higher-education institutions on the capacity to innovate in the economies in Europe. Providing insights into the contribution of higher education to the innovative capacity of the EU economies is crucial for policy making and the…

Matching Up to the Information Society: An Evaluation of the EU, the EU Accession Countries, Switzerland and the United States. Summary

ERIC Educational Resources Information Center

Graafland-Essers, Irma; Cremonini, Leon; Ettedgui, Emile; Botterman, Maarten

2003-01-01

This report presents the current understanding of the advancement of the Information Society within the European Union and countries that are up for accession in 2004, and is based on the SIBIS (Statistical Indicators Benchmarking the Information Society) surveys and analyses per SIBIS theme and country. The report is unique in its coherent and…

Matching Up to the Information Society: An Evaluation of the EU, the EU Accession Countries, Switzerland and the United States

ERIC Educational Resources Information Center

Graafland-Essers, Irma; Cremonini, Leon; Ettedgui, Emile; Botterman, Maarten

2003-01-01

This report presents the current understanding of the advancement of the Information Society within the European Union and countries that are up for accession in 2004, and is based on the SIBIS (Statistical Indicators Benchmarking the Information Society) surveys and analyses per SIBIS theme and country. The report is unique in its coherent and…

Making Higher Education More European through Student Mobility? Revisiting EU Initiatives in the Context of the Bologna Process

ERIC Educational Resources Information Center

Papatsiba, Vassiliki

2006-01-01

This paper focuses on the analysis of student mobility in the EU as a means to stimulate convergence of diverse higher education systems. The argument is based on official texts and other texts of political communication of the European Commission. The following discussion is placed within the current context of the Bologna process and its aim to…

An integrated and sustainable EU health information system: national public health institutes' needs and possible benefits.

PubMed

Bogaert, Petronille; Van Oyen, Herman

2017-01-01

Although sound data and health information are at the basis of evidence-based policy-making and research, still no single, integrated and sustainable EU-wide public health monitoring system or health information system exists. BRIDGE Health is working towards an EU health information and data generation network covering major EU health policy areas. A stakeholder consultation with national public health institutes was organised to identify the needs to strengthen the current EU health information system and to identify its possible benefits. Five key issues for improvement were identified: (1) coherence, coordination and sustainability; (2) data harmonization, collection, processing and reporting; (3) comparison and benchmarking; (4) knowledge sharing and capacity building; and (5) transferability of health information into evidence-based policy making. The vision of an improved EU health information system was formulated and the possible benefits in relation to six target groups. Through this consultation, BRIDGE Health has identified the continuous need to strengthen the EU health information system. A better system is about sustainability, better coordination, governance and collaboration among national health information systems and stakeholders to jointly improve, harmonise, standardise and analyse health information. More and better sharing of this comparable health data allows for more and better comparative health research, international benchmarking, national and EU-wide public health monitoring. This should be developed with the view to provide the tools to fight both common and individual challenges faced by the Members States and their politicians.

Novel yellow-emitting Sr8MgLn(PO4)7:Eu2+ (Ln=Y, La) phosphors for applications in white LEDs with excellent color rendering index.

PubMed

Huang, Chien-Hao; Chen, Teng-Ming

2011-06-20

Eu(2+)-activated Sr(8)MgY(PO(4))(7) and Sr(8)MgLa(PO(4))(7) yellow-emitting phosphors were successfully synthesized by solid-state reactions for applications in excellent color rendering index white light-emitting diodes (LEDs). The excitation and reflectance spectra of these phosphors show broad band excitation and absorption in the 250-450 nm near-ultraviolet region, which is ascribed to the 4f(7) → 4f(6)5d(1) transitions of Eu(2+). Therefore, these phosphors meet the application requirements for near-UV LED chips. Upon excitation at 400 nm, the Sr(8)MgY(PO(4))(7):Eu(2+) and Sr(8)MgLa(PO(4))(7):Eu(2+) phosphors exhibit strong yellow emissions centered at 518, 610, and 611 nm with better thermal stability than (Ba,Sr)(2)SiO(4) (570 nm) commodity phosphors. The composition-optimized concentrations of Eu(2+) in Sr(8)MgLa(PO(4))(7):Eu(2+) and Sr(8)MgY(PO(4))(7):Eu(2+) phosphors were determined to be 0.01 and 0.03 mol, respectively. A warm white-light near-UV LED was fabricated using a near-UV 400 nm chip pumped by a phosphor blend of blue-emitting BaMgAl(10)O(17):Eu(2+) and yellow-emitting Sr(8)MgY(PO(4))(7):0.01Eu(2+) or Sr(8)MgLa(PO(4))(7):0.03Eu(2+), driven by a 350 mA current. The Sr(8)MgY(PO(4))(7):0.01Eu(2+) and Sr(8)MgLa(PO(4))(7):0.03Eu(2+) containing LEDs produced a white light with Commission International de I'Eclairage (CIE) chromaticity coordinates of (0.348, 0.357) and (0.365, 0.328), warm correlated color temperatures of 4705 and 4100 K, and excellent color rendering indices of 95.375 and 91.75, respectively. © 2011 American Chemical Society

Inorganic scintillation detectors based on Eu-activated phosphors for 192Ir brachytherapy

PubMed Central

Kertzscher, Gustavo; Beddar, Sam

2017-01-01

The availability of real-time treatment verification during high-dose-rate (HDR) brachytherapy is currently limited. Therefore, we studied the luminescence properties of the widely commercially available scintillators using the inorganic materials Eu-activated phosphors Y2O3:Eu, YVO4:Eu, Y2O2S:Eu, and Gd2O2S:Eu to determine whether they could be used to accurately and precisely verify HDR brachytherapy doses in real time. The suitability for HDR brachytherapy of inorganic scintillation detectors (ISDs) based on the 4 Eu-activated phosphors in powder form was determined based on experiments with a 192Ir HDR brachytherapy source. The scintillation intensities of the phosphors were 16 to 134 times greater than that of the commonly used organic plastic scintillator BCF-12. High signal intensities were achieved with an optimized packing density of the phosphor mixture and with a shortened fiber-optic cable. The influence of contaminating Cerenkov and fluorescence light induced in the fiber-optic cable (stem signal) was adequately suppressed by inserting between the fiber-optic cable and the photodetector a 25-nm band-pass filter centered at the emission peak. The spurious photoluminescence signal induced by the stem signal was suppressed by placing a long-pass filter between the scintillation detector volume and the fiber-optic cable. The time-dependent luminescence properties of the phosphors were quantified by measuring the non-constant scintillation during irradiation and the afterglow after the brachytherapy source had retracted. We demonstrated that a mixture of Y2O3:Eu and YVO4:Eu suppressed the time-dependence of the ISDs and that the time-dependence of Y2O2S:Eu and Gd2O2S:Eu introduced large measurement inaccuracies. We conclude that ISDs based on a mixture of Y2O3:Eu and YVO4:Eu are promising candidates for accurate and precise real-time verification technology for HDR BT that is cost effective and straightforward to manufacture. Widespread dissemination of this technology could lead to an improved understanding of error types and frequencies during BT and to improved patient safety during treatment. PMID:28475494

Inorganic scintillation detectors based on Eu-activated phosphors for 192Ir brachytherapy

NASA Astrophysics Data System (ADS)

Kertzscher, Gustavo; Beddar, Sam

2017-06-01

The availability of real-time treatment verification during high-dose-rate (HDR) brachytherapy is currently limited. Therefore, we studied the luminescence properties of the widely commercially available scintillators using the inorganic materials Eu-activated phosphors Y2O3:Eu, YVO4:Eu, Y2O2S:Eu, and Gd2O2S:Eu to determine whether they could be used to accurately and precisely verify HDR brachytherapy doses in real time. The suitability for HDR brachytherapy of inorganic scintillation detectors (ISDs) based on the 4 Eu-activated phosphors in powder form was determined based on experiments with a 192Ir HDR brachytherapy source. The scintillation intensities of the phosphors were 16-134 times greater than that of the commonly used organic plastic scintillator BCF-12. High signal intensities were achieved with an optimized packing density of the phosphor mixture and with a shortened fiber-optic cable. The influence of contaminating Cerenkov and fluorescence light induced in the fiber-optic cable (stem signal) was adequately suppressed by inserting between the fiber-optic cable and the photodetector a 25 nm band-pass filter centered at the emission peak. The spurious photoluminescence signal induced by the stem signal was suppressed by placing a long-pass filter between the scintillation detector volume and the fiber-optic cable. The time-dependent luminescence properties of the phosphors were quantified by measuring the non-constant scintillation during irradiation and the afterglow after the brachytherapy source had retracted. We demonstrated that a mixture of Y2O3:Eu and YVO4:Eu suppressed the time-dependence of the ISDs and that the time-dependence of Y2O2S:Eu and Gd2O2S:Eu introduced large measurement inaccuracies. We conclude that ISDs based on a mixture of Y2O3:Eu and YVO4:Eu are promising candidates for accurate and precise real-time verification technology for HDR BT that is cost effective and straightforward to manufacture. Widespread dissemination of this technology could lead to an improved understanding of error types and frequencies during BT and to improved patient safety during treatment.

Improved Marine Waters Monitoring

NASA Astrophysics Data System (ADS)

Palazov, Atanas; Yakushev, Evgeniy; Milkova, Tanya; Slabakova, Violeta; Hristova, Ognyana

2017-04-01

IMAMO - Improved Marine Waters Monitoring is a project under the Programme BG02: Improved monitoring of marine waters, managed by Bulgarian Ministry of environment and waters and co-financed by the Financial Mechanism of the European Economic Area (EEA FM) 2009 - 2014. Project Beneficiary is the Institute of oceanology - Bulgarian Academy of Sciences with two partners: Norwegian Institute for Water Research and Bulgarian Black Sea Basin Directorate. The Project aims to improve the monitoring capacity and expertise of the organizations responsible for marine waters monitoring in Bulgaria to meet the requirements of EU and national legislation. The main outcomes are to fill the gaps in information from the Initial assessment of the marine environment and to collect data to assess the current ecological status of marine waters including information as a base for revision of ecological targets established by the monitoring programme prepared in 2014 under Art. 11 of MSFD. Project activities are targeted to ensure data for Descriptors 5, 8 and 9. IMAMO aims to increase the institutional capacity of the Bulgarian partners related to the monitoring and assessment of the Black Sea environment. The main outputs are: establishment of real time monitoring and set up of accredited laboratory facilities for marine waters and sediments chemical analysis to ensure the ability of Bulgarian partners to monitor progress of subsequent measures undertaken.

Somatic cell nuclear transfer cloning: practical applications and current legislation.

PubMed

Niemann, H; Lucas-Hahn, A

2012-08-01

Somatic cloning is emerging as a new biotechnology by which the opportunities arising from the advances in molecular genetics and genome analysis can be implemented in animal breeding. Significant improvements have been made in SCNT protocols in the past years which now allow to embarking on practical applications. The main areas of application of SCNT are: Reproductive cloning, therapeutic cloning and basic research. A great application potential of SCNT based cloning is the production of genetically modified (transgenic) animals. Somatic cell nuclear transfer based transgenic animal production has significant advances over the previously employed microinjection of foreign DNA into pronuclei of zygotes. This cell based transgenesis is compatible with gene targeting and allows both, the addition of a specific gene and the deletion of an endogenous gene. Efficient transgenic animal production provides numerous opportunities for agriculture and biomedicine. Regulatory agencies around the world have agreed that food derived from cloned animals and their offspring is safe and there is no scientific basis for questioning this. Commercial application of somatic cloning within the EU is via the Novel Food regulation EC No. 258/97. Somatic cloning raises novel questions regarding the ethical and moral status of animals and their welfare which has prompted a controversial discussion in Europe which has not yet been resolved. © 2012 Blackwell Verlag GmbH.