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European Union System for the Evaluation of Substances (EUSES). Principles and structure.

In the European Union, Directive 92/32/EC and EC Council Regulation (EC) 793/93 require the risk assessment of new and existing substances, respectively. Principles for this risk assessment have been laid down, supported by a detailed package of Technical Guidance Documents. Against this background the European Union System for the Evaluation of Substances (EUSES) has been developed. This software can be used to carry out tiered risk assessments of increasing complexity on the basis of increasing data requirements. The exposure assessment, effects assessment and risk characterisation are carried out for environmental populations as well as for human beings, including workers, consumers and man exposed through the environment. EUSES is the result of a co-ordinated effort of EU Member States, the European Commission and the European Chemical Industry.

Animals↗

The European TrustHealth project experiences with implementing a security infrastructure.

Accepting the shared care paradigm, communication and co-operation required between health care establishments must be provided in a trustworthy way. The solution for establishing such trustworthy environment has to be based on a common policy framework, on services, and mechanisms, which have been standardised. In Europe, the legal framework, other policy issues, and the services and mechanisms needed have been developed within projects launched by the European Commission, by the European standards body CEN as well as by temporarily established groups. Within the European TrustHealth projects. a security infrastructure for trustworthy health telematics applications has been specified, implemented, and evaluated. It is based on Health Professional Cards and Trusted Third Party services. Experiences regarding organisational and technological implications of the specification, implementation, maintenance, and evaluation of such a security infrastructure are described on the basis of the ONOCONET example. For the complete software lifecycle, the UML methodology has been deployed.

Communication↗

Policy Interpretation Network on Children's Health and Environment.

AIM: The main objective of PINCHE is to provide policy recommendations aiming at protecting children's health and environment based on completed scientific research. The project focused on four themes: indoor and outdoor air pollutants, carcinogens, neurotoxicants, and noise. The data were evaluated in workpackages on exposure assessment, epidemiology, toxicology, and risk and health impact assessment. The data were analysed according to a framework of questions. The workpackage on socioeconomic factors studied the influence of socioeconomic status on exposures and on health effects. In the workpackage on science-policy interface, recommendations on how to improve children's environmental health were formulated. RESULTS: The policy recommendations resulting from the analysis were grouped according to relevant policy levels: European Commission or the European Parliament, member states and other stakeholders at regional or local level. These recommendations are general guidelines for taking action. Regional differences and variation must be reflected when policy is actually implemented. In addition, recommendations related to education and personal behaviour are presented in the reports. CONCLUSIONS: The policy recommendations are important input for policy advisers, policy makers and public health authorities at all policy levels. The recommendations are also of direct relevance to interest groups, such as environmental NGOs including child health and advocacy groups. The policy recommendations for each policy level were prioritized. High priorities were given to reduce exposure to environmental tobacco smoke, transport related air pollution, indoor air and mercury.

Advisory Committees↗

The EFQM excellence model: European and Dutch experiences with the EFQM approach in health care. European Foundation for Quality Management.

One way to meet the challenges in creating a high performance organization in health care is the approach of the European Foundation for Quality Management (EFQM). The Foundation is in the tradition of the American Malcolm Baldrige Award and was initiated by the European Commission and 14 European multi-national organizations in 1988. The essence of the approach is the EFQM Model, which can be used as a self-assessment instrument on all levels of a health care organization and as an auditing instrument for the Quality Award. In 1999 the EFQM Model was revised but its principles remained the same. In The Netherlands many health care organizations apply the EFQM Model. In addition to improvement projects, peer review of professional practices, accreditation and certification, the EFQM Approach is used mainly as a framework for quality management and as a conceptualization for organizational excellence. The Dutch National Institute for Quality, the Instituut Nederlandse Kwaliteit, delivers training and supports self-assessment and runs the Dutch quality award programme. Two specific guidelines for health care organizations, 'Positioning and Improving' and 'Self-Assessment', have been developed and are used frequently. To illustrate the EFQM approach in The Netherlands, the improvement project of the Jellinek Centre is described. The Jellinek Centre conducted internal and external assessments and received in 1996, as the first health care organization, the Dutch Quality Prize.

Academies and Institutes↗

The European Radiobiology Archives (ERA)--content, structure and use illustrated by an example.

The European Radiobiology Archives (ERA), supported by the European Commission and the European Late Effect Project Group (EULEP), together with the US National Radiobiology Archives (NRA) and the Japanese Radiobiology Archives (JRA) have collected all information still available on long-term animal experiments, including some selected human studies. The archives consist of a database in Microsoft Access, a website, databases of references and information on the use of the database. At present, the archives contain a description of the exposure conditions, animal strains, etc. from approximately 350,000 individuals; data on survival and pathology are available from approximately 200,000 individuals. Care has been taken to render pathological diagnoses compatible among different studies and to allow the lumping of pathological diagnoses into more general classes. 'Forms' in Access with an underlying computer code facilitate the use of the database. This paper describes the structure and content of the archives and illustrates an example for a possible analysis of such data.

Animals↗

European whole body counter measurement intercomparison.

In order to test the common quality standards for the performance of measurements of internal radioactivity, the European Commission funded a European intercomparison of whole body counters, which was organized and carried out by the Institut fuer Strahlenhygiene (part of the German Bundesamt fuer Strahlenschutz). Forty-four whole body counting facilities from forty-two institutions in nineteen countries (the fifteen member states of the European Union plus Hungary, the Czech Republic, Switzerland and Norway) took part in this intercomparison, which made it the most comprehensive ever carried out in Europe. For the study, the 70 kg tissue equivalent St Petersburg phantom was used with rods containing 40K, 57Co, 60Co, and 137Cs. The overall results of the whole body counter study were rather good.

Cesium Radioisotopes↗

What the French working conditions surveys tell us.

Since 1978, France's Ministry of Labour and the National Statistical Institute (INSEE) have carried out four large-scale sample surveys on working conditions among approximately 20,000 workers, questioned by survey-takers at home, that provide invaluable descriptive information on how work is changing. The last survey published was from 1998, and the 2005 survey is being processed at the time of writing. Taking a lead from this example among others, the European Commission tasked the European Foundation for the Improvement of Living and Working Conditions to carry out similar surveys in EU countries in 1990, 1995, 2000, and now 2005. Between them, these surveys portray an alarming situation where workers are seeing their working conditions getting worse. Another survey using a different methodology, carried out by occupational doctors during health checks on 50,000 workers--the Sumer survey, from the French acronym for the health risk screening program--done for the Ministry of Labour in 1994 and 2003, points to the same general trends. In both France and the broader European Union (EU), physical demands and risks are not lessening, mental workload is growing, working hours are more diverse and less regular, work paces more demanding, compressed deadlines reduce job predictability and task discretion. . . . But at the same time, workers report having more leeway in discharging responsibilities that have expanded due to the rise in skill levels and new forms of work organization.

Data Collection↗

The "Road to Safety" in Irish children over the past five years.

Motor vehicle crashes account for 1 in 5 of all childhood deaths across The EU. In the year 2000, the World Health Organization ranked road traffic accidents as the ninth leading cause of mortality, accounting for 2.3% of deaths worldwide. In 1997, the European Commission published the European Union RoadSafety Programme. This had been prepared against a background of 45,000 road- related fatalities and 1.6 million injuries occurring within the European Union each year. At that stage, Ireland had not yet developed a formal national road safety strategy. By 1998 however, the "Road to Safety" government strategy was put in place with the aim of reducing deaths and serious injuries from road traffic accidents by at least 20% over the five year period beginning 1998 and ending 2002. Age-standardised mortality rates for road accidents in children (0-14 years old) in Ireland are 3.61 per 100,000 as compared to 2.31 per 100,000 in Sweden and thus much needs to be done to reduce this unacceptably high road toll in Ireland. To date there has been insufficient evidence available for childhood road-related accidents occurring within Ireland.

Accident Prevention↗

Quantitative in vitro assessment of phototoxicity using a human skin model, Skin2.

The ability to accurately predict the phototoxic potential of personal and skin care products remains a key element in assessing the safety of premarketed products. To find a reliable in vitro alternative test for photoirritancy, the European Commission and the European Cosmetic Association are conducting a 3-year, European validation study. Based on the results of this study, an in vitro photoirritancy method will be selected for incorporation into new international guidelines for photoirritancy testing. As a part of this study, Skin2, a cultured human skin system, was used to evaluate the phototoxic potential of chemicals with known photoirritative properties. The Skin2 ZK1351, a 3-dimensional co-culture system, consists of dermal fibroblasts and a multilayered epidermis comprising differentiated keratinocytes. This product line has previously been used to evaluate the irritative potential of topically applied ingredients and products. In this study, various concentrations of the test chemicals were applied to the epidermal side of the Skin2 tissue for contact times of 1 h or 24 h and then the tissue was exposed to 2.9 J/cm2 of ultraviolet A (UVA) radiation. Treated but nonirradiated tissues were also assayed to predict the cytotoxic potential of the test chemicals, which could mask the phototoxic reaction. After exposure, the tissue substrates were rinsed free of test chemicals and allowed to recover for 24 h. Following this incubation, the MTT reduction assay was used to assess cytotoxicity.(ABSTRACT TRUNCATED AT 250 WORDS)

Benzophenones↗

ILAE Commission of European Affairs Subcommission on European Guidelines 1998-2001: The provision of epilepsy care across Europe.

PURPOSE: To assess the needs and resources available in the provision of basic epilepsy care across Europe. METHODS: A mailed questionnaire was used, the European Epilepsy Services inventory (EESI). The EESI was distributed to all 36 European chapters of the International League Against Epilepsy (ILAE), and answers were obtained from 32, a response rate of 89%. For the purpose of studying trends across Europe, the chapters were divided into a Western, an Eastern, a Central, and a Southern group. RESULTS: The survey results showed that there was a wide range in the number of physicians and specialists involved in epilepsy care across Europe, with a trend toward higher numbers of neurologists, pediatricians, and pediatric neurologists in Eastern Europe. Many different specialties were involved in epilepsy care, and many chapters reported differences in the provision of care across their countries, with less possibility for patients to see a specialist in the least provided areas, where most epilepsy patients were cared for by general practitioners and internists. Problems with high costs of the newer antiepileptic drugs were most pronounced in Eastern Europe. Problems with lack of comprehensive care and of epilepsy specialists, with stigma and social problems, and with insufficient professional education and knowledge about epilepsy were reported all across Europe. CONCLUSIONS: Knowledge about differences in the pattern of provision of epilepsy care and about the main problems encountered by the European ILAE chapters is of importance in the continuing efforts to improve management of epilepsy all over Europe.

Adult↗

Calculation of the intake of three intense sweeteners in young insulin-dependent diabetics.

In 1994, European Directive 94/35/CE authorised the use as food additives of five intense sweeteners for which Acceptable Daily Intakes (ADI) were established. The same directive stipulated that member states should organise a monitoring system to determine the consumption of these substances. Diabetic children are normally considered to constitute a group with a high consumption of sweeteners (European Commission, 1998. Report on Methodology for the Monitoring of Food Additives Intake across the European Union. Report of the Scientific Cooperation, Task 4.2 SCOOP/INT/REPORT/2. European Commission Directorate General III, Brussels.). A stepwise approach to the food additive intake in the general population had shown that three of the five authorised intense sweeteners (aspartame, saccharin and acesulfame K) are used at particularly high levels in sugar-free foods and are also very commonly utilised as table-top sweeteners. This paper presents the results of a food intake survey conducted in a group of French, insulin-dependent children in 1997, aimed at estimating the Theoretical Maximum Daily Intake (TMDI) for these three sweeteners and comparing this with the relevant ADI values. A 5-day diary questionnaire was used to estimate the intake of sugar-free, artificially sweetened foods and table-top sweeteners. When assessing the intake of each additive, all sugar-free products were assumed to be sweetened using a single sweetener at its maximum authorised level. This study was performed in five age groups, and based on the mean and 97.5th percentile of the distribution of consumption, demonstrated that it was unlikely that total exposure could rise above the ADI.

Adolescent↗

An Internet compendium of analytical methods and spectroscopic information for monomers and additives used in food packaging plastics.

An internet website (http:¿cpf.jrc.it/smt/) has been produced as a means of dissemination of methods of analysis and supporting spectroscopic information on monomers and additives used for food contact materials (principally packaging). The site which is aimed primarily at assisting food control laboratories in the European Union contains analytical information on monomers, starting substances and additives used in the manufacture of plastics materials. A searchable index is provided giving PM and CAS numbers for each of 255 substances. For each substance a data sheet gives regulatory information, chemical structures, physico-chemical information and background information on the use of the substance in particular plastics, and the food packaging applications. For monomers and starting substances (155 compounds) the infra-red and mass spectra are provided, and for additives (100 compounds); additionally proton NMR are available for about 50% of the entries. Where analytical methods have been developed for determining these substances as residual amounts in plastics or as trace amounts in food simulants these methods are also on the website. All information is provided in portable document file (PDF) format which means that high quality copies can be readily printed, using freely available Adobe Acrobat Reader software. The website will in future be maintained and up-dated by the European Commission's Joint Research Centre (JRC) as new substances are authorized for use by the European Commission (DG-ENTR formerly DGIII). Where analytical laboratories (food control or other) require reference substances these can be obtained free-of-charge from a reference collection housed at the JRC and maintained in conjunction with this website compendium.

Data Display↗

Evaluation of the European Union Programme of Community Action on Health Promotion, Information, Education and Training 1996-2000.

The Programme of Community Action on Health Promotion, Information, Education and Training 1996-2000 was administered by the European Commission's Services in DGV Luxembourg. The programme was a consequence of a decision of the European Parliament and the Council of the European Union in March 1996. Middlesex University Health Research Centre won the tender to evaluate this programme. In this paper the evaluation team disseminate some of the findings that are pertinent to the international health promotion community. Key findings include significant differences in number of applications and in acceptance rates for different Member States. The expert assessors' opinions of the programme suggest a number of problems with its administration. Some projects were awarded commendably high ratings and others were very weak. The most serious weakness of many of the supported projects is lack of any internal evaluation. In order to broaden the scope of the second phase of the evaluation of this programme, more open communication and dialogue will be needed between all of the stakeholders. This implies a change in the culture of the European Commission's Services which, in the case of the units involved with this evaluation, are lacking in efficiency, openness and transparency.

Community Networks↗

[Third statistical report on the numbers of laboratory animals used in the European Union--tendencies, problems, decisions].

In 2003, the European Commission has published its third statistical report on the numbers of laboratory animals used in the European Union, in which the data of 1999 are analysed. For the first time, with the exception of Germany, the data presented were raised on the basis of a new registration scheme. The significance of these data is limited due to deficiencies of the tables used, restricted comparability with previously raised data, and lacking relevance to the current situation. Despite this imperfect basis, the European Commission concludes in its report that there has been a significant reduction in the number of laboratory animals used in the EU compared to the previous statistics. This statement must be regarded critically as several national statistics of the last years verify that the number of laboratory animals used has in fact increased. According to the comments of various national authorities included in the report, particularly genetic engineering is responsible for the increase in animal numbers.

Animal Welfare↗

Developing curriculum in nursing informatics in Europe.

The NIGHTINGALE Project (NIGHTINGALE Project: HC1109 DGXIII Contract and Technical Annex, European Commission, December 1995) which started on the 1st of January, 1996, after the approval of the European Commission, has a 36 month duration. It is essential in planning and implementing a strategy in training the nursing profession in using and applying healthcare information systems. NIGHTINGALE contributes towards the appropriate use of the developed telematics infrastructure across Europe by educating and training nurses in a harmonious way across Europe in the upcoming field of nursing informatics. NIGHTINGALE develops courseware material based on the curriculum development process using multimedia technologies. Computer based training software packages in nursing informatics will be the basis of the training material and the corresponding courses. CD-ROM based training and reference material will also be provided in the courses whereas the traditional booklets, teaching material and textbooks can also play an adequate role in training. NIGHTINGALE will disseminate all information and courseware material freely to all interested parties through the publications of the proceedings of the conferences, through the establishment of the world wide web (WWW) server in nursing informatics for Europe (http://www.dn.uoa.gr/nightingale), which will become a depository of nursing information knowledge across Europe as well as a dissemination node of nursing informatics throughout the European members states for the benefit and welfare of the European citizen.

CD-ROM↗

A European perspective on hazardous air pollutants.

Air pollution is considered to be a major threat to human health. Protection of human health from adverse effects of air pollutants and elimination or reduction of exposure to hazardous air pollutants was therefore the major consideration of the World Health Organization to establish the Air Quality Guidelines for Europe. The 2nd edition of the WHO guidelines has recently been published. In establishing pollutant levels below which exposure does not constitute a significant public health risk, the guidelines provide information for regulatory authorities on a national or international level to set standards or limit values for air pollutants. The guidelines also form a basis for the development of risk management or risk abatement strategies. During the recent revision of the WHO Air Quality Guidelines for Europe, DG Environment of the European Commission developed a Framework Directive on Air Quality (96/62/EC) and a number of Daughter Directives dealing with individual pollutants. It was agreed that the European Commission should use the WHO Air Quality Guidelines as starting point for deriving limit values for a number of major air pollutants in the European Union. This paper describes the revision of the WHO guidelines and addresses the differences between guidelines and legally binding standards as for instance the limit values established by the EU.

Air↗

Partial degradation of five pesticides and an industrial pollutant by ozonation in a pilot-plant scale reactor.

Aqueous solutions of a mixture of several pesticides (alachlor, atrazine, chlorfenvinphos, diuron and isoproturon), considered PS (priority substances) by the European Commission, and an intermediate product of the pharmaceutical industry (alpha-methylphenylglycine, MPG) chosen as a model industrial pollutant, have been degraded at pilot-plant scale using ozonation. This study is part of a large research project [CADOX Project, A Coupled Advanced Oxidation-Biological Process for Recycling of Industrial Wastewater Containing Persistent Organic Contaminants, Contract No.: EVK1-CT-2002-00122, European Commission, http://www.psa.es/webeng/projects/cadox/index.html] founded by the European Union that inquires into the potential coupling between chemical and biological oxidations for the removal of toxic or non-biodegradable contaminants from water. The evolution of pollutant concentration, TOC mineralization, generation of inorganic species and consumption of O3 have been followed in order to visualize the chemical treatment effectiveness. Although complete mineralization is hard to accomplish, and large amounts of the oxidant are required to lower the organic content of the solutions, the possibility of ozonation cannot be ruled out if partial degradation is the final goal wanted. In this sense, Zahn-Wellens biodegradability tests of the ozonated MPG solutions have been performed, and the possibility of a further coupling with a secondary biological treatment for complete organic removal is envisaged.

Acetamides↗

[Ochratoxin A contamination of cereal grain harvested in 2003 and 2004 years].

The analysis of ochratoxin A--mycotoxin produced by widely distributed Aspergillus and Penicillium--of cereal grain harvested in 2003 - 2004 years were performed by immunoaffinity column clean-up and HPLC with fluorescence detection. This survey examined 282 samples of raw grain wheat, rye, barley and oat 13.8% of all samples contaminated by ochratoxin A in the range 0.2-33.3 mg/kg. Calculation made on the basis of the obtained means showed that the daily ochratoxin A intake of human from cereal grain were from 1.58 to 2.84 ng/kg b.w. Scientific Committee for Food of the European Commission suggested that it was prudent to reduce exposure to ochratoxin A as much as possible below 5 ng/kg bw/day. Codex Alimentarius and European Commission have established maximum permissible level of 5 mg/kg for ochratoxin A in raw cereal grains.

Aspergillus ochraceus↗