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The EEC policy in the hazard assessment of new chemicals.

The sheer number of new chemicals produced each year poses problems to ensure that no dangerous products are brought in to use in the Community. Therefore the Council of Ministers of the European Communities has adopted on September 18, 1979 a Community legislation with respect to the notification of new chemicals. This is the so called sixth amendment of the Council directive of 27 June 1967 relating to the classification, packaging and labelling of dangerous substances. The purpose of this directive is to approximate the laws, regulations and administrative provisions of the ten Member States on: a) the notification of new chemical substances and b) the classification, packaging and labelling of substances dangerous to man and the environment which are placed on the market (including imported products) in the Member States of the Community. When giving this pre-marketing notification, the technical dossier requires, amongst others, the results of tests, of physico-chemical properties and toxicological and ecotoxicological parameters, following a three level hierarchical or step-sequence test system based on the quantities of the substances marketed. The first level concerns a mandatory base-set or level 0, the so called Annex VII, followed by a level 1 and level 2 testsystem (Annex VIII).

Animals↗

European veterinary education: a bridge to quality.

The aim of this review is to provide an insight into the current state of, and future changes in, veterinary education within the European Community, as well as the role of the European Association of Establishments for Veterinary Education (EAEVE) in evaluating and raising standards of education and training. It also describes the role of EAEVE in developing strategies for changes in the future. Veterinary schools have traditionally aimed at producing the omnicompetent veterinarian at graduation. Many have questioned whether this is possible, and a recent European Commission (EC) funded market survey has confirmed that this is indeed an impossible task and has identified the requirements of society within the European Union (EU) for veterinary services in the future. There is however a need to change the current 1978 European Directive. The current mechanisms which have been used by EAEVE to evaluate over 100 veterinary schools in Europe and their relationship with other systems of appraisal are described. The future of veterinary education within the context of higher education in Europe as part of the Bologna process and in relation to standards of veterinary education worldwide are discussed. Whilst the merits of standardisation of educational quality so that there can be mutual recognition of qualifications are supported, the need to preserve the strengths associated with the diversity of approaches and teaching methods is strongly advocated.

Accreditation↗

Predicting faecal indicator fluxes using digital land use data in the UK's sentinel Water Framework Directive catchment: the Ribble study.

The Ribble drainage basin is the single UK sentinel study area chosen for examining the implementation of the EU Water Framework Directive (WFD 20/60/EC). The study which has generated the data for this paper was initiated to quantify 'catchment-derived' fluxes of faecal indicators originating from both point and diffuse sources to inform the competent authorities on the potential for, and prioritization of, further options for reducing the faecal indicator loadings to this crucial coastal environment. It represents the first UK drainage basin-scale 'profile' of faecal indicator sources as recommended by WHO [1999. Health Based Monitoring of Recreational Waters: The Feasibility of a New Approach; the "Annapolis Protocol". World Health Organisation Geneva, Switzerland; 2003. Guidelines for Safe Recreational-Water Environments Volume 1: Coastal and Fresh-Waters. World Health Organisation Geneva, Switzerland] and incorporated into current drafts of the revised Bathing Water Directive [Anon, 2004. Council of the European Communities Amended proposal for a Directive of the European Parliament and of the Council concerning the management of bathing water quality. Brussels 23rd June]. This paper focuses on the relationships between land use and faecal indicator organism concentrations in surface waters within this very large drainage basin (1583 km2) containing some extensive urban areas. A geographical information system comprising readily available digital elevation, remotely sensed land cover and digital map data was used to generate the land use variables for subcatchments draining to 41 locations across the study area. Presumptive concentrations of coliforms, Escherichia coli and enterococci (colony forming unit (cfu) 100 ml(-1)) were measured at each location on at least 20 occasions over a 44-day period within the 2002 bathing season. The sampling programme targeted hydrograph events. Hydrometric records were used to allocate results as either base flow or high flow. At each site, geometric mean faecal indicator organism concentrations were significantly elevated at high flow compared to base flow. Stepwise regression modelling produced statistically significant models predicting geometric mean base and high-flow faecal indicator organism concentrations from land use variables (r2: 49.5-68.1%). The dominant predictor variable in each case was the proportion of built-up land in subcatchments, suggesting that this land use type, with associated sewage-related inputs, is a critical source of faecal indicator organisms in this drainage basin.

Biomarkers↗

Validity of ECSC prediction equations for spirometric indices in Dutch conscripts.

A study was performed to determine whether prediction equations issued by the European Community for Steel and Coal (ECSC) and the European Respiratory Society (ERS) fit spirometric data in young adult males. The study comprised 246 randomly selected Dutch conscripts, who participated in the study on the basis of informed consent. A questionnaire was used to assess respiratory symptoms and smoking habits. Maximal expiratory flow-volume curves were obtained with a rolling seal spirometer, and summary statistics selected according to ECSC/ERS recommendations. In addition, standing height and body weight were obtained. We analysed the data of 100 conscripts of European descent, with no history of respiratory symptoms. They were all life-long nonsmokers. Their mean (SD) age was 18 (0.12) yrs (range 17.9-19.0 yrs), with a mean (SD) standing height of 1.84 (0.06) m (range 1.68-2.00 m). The data for forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and maximal mid-expiratory flow (MMEF) agreed well with ECSC predictions; 95% confidence intervals (95% CI) of differences between measured and predicted values were -0.174 to 0.044 l, -0.012 to 0.174 l.s-1 and -0.114 to 0.302 l.s-1, respectively. Peak expiratory flow was systematically larger than predicted, as was FEV1 % FVC (95% CI 0.74 to 1.31 l.s-1 and 2.50 to 5.24%, respectively), due to the intercept being inappropriate. The residual standard deviation in the conscripts was somewhat less than in the ECSC/ERS predictions equations, except for peak expiratory flow (PEF).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

FESCC survey on accreditation and post-graduate training in clinical chemistry in European countries. Federation of European Societies of Clinical Chemistry.

Promotion of the professional growth and development of specialists in the field of clinical chemistry in European countries, and harmonisation of quality assessment and accreditation procedures are listed among the main goals and activities of Federation of European Societies of Clinical Chemistry (FESCC), according to its 1999-2000 strategic plan. The European countries that are members of the European Union are in the process of establishing the "European Register for Clinical Chemists", based on minimum standards of education, training and experience as defined by the European Communities Confederation of Clinical Chemists (EC4). Many other European countries would like to adapt their system of professional education to this model. Data on post-graduate training in EC4 FESCC members have already been gathered in 1998. However, at the present time, there is no detailed knowledge of pre- and post-graduate professional education of specialists in clinical chemistry in the non-EC4 European countries. FESCC launched a survey in July 1998 in order to gather this information with the hope to start a database about existing systems. All FESCC members received the same questionnaire on accreditation (seven questions) and non-EC4 FESCC members received an additional questionnaire with 11 questions related to post-graduate training in clinical chemistry. The response rate of the 35 FESCC member countries was 93% from the 15 EC4 members (14 responses/15 countries) and 80% from the 20-non-EC4 (16 responses/20 countries). The heterogeneity of the data on post-graduate training in clinical chemistry indicates that a great effort will be needed before harmonisation is reached. These results, however, will provide an interesting basis for further discussion and promotion of post-graduate training in clinical chemistry. The data provided on accreditation show that the total number of accredited laboratories was relatively low in EC4 countries and even lower in non-EC4 members. It was not surprising to see that the number of accredited laboratories was the highest in the two countries which started accreditation the earliest (i.e. Sweden and UK, 1992). This situation, however, is changing at a fast rate in most countries and the number of the accredited sites is expected to increase rapidly in the next few years.

Accreditation↗

[A complete clinical trial register is already a reality in the paediatric field].

Clinical trials have a fundamental role in promoting an evidence based use of drugs in adults and in children. However, it is often difficult to identify the few paediatric studies carried out and to thus implement knowledge derived from them. Furthermore, studies that are stopped prematurely or that have insignificant or negative results often remain unpublished, leading to duplication of effort by researchers, waste of resources and concealment of potentially toxic risks. The European Community decided to support the development of a European register of clinical trials in children as part of the Fifth Framework Thematic Programme "Quality of Life" in 2002. The project DEC-net is coordinated by the Laboratory of Mother and Child Health of the Mario Negri Institute for Pharmaceutical Research in Milan and currently involves members of four countries; France, Italy, Spain and the United Kingdom. It is unique in that it is the first population oriented clinical trial register. Such a register represents a useful source for planning new studies, promoting communications and collaborations between researchers, facilitating patient access and recruitment into trials, preventing trial duplication and inappropriate funding and identifying the therapeutic needs of children that remain neglected. It will also allow for active monitoring of new or evolved knowledge of drug therapies.

Child↗

Murphy v. Bord Telecom Eireann, 4 February 1988.

Upon referral by the Irish High Court, the European Court of Justice held that, under Article 119 of the Treaty of Rome, the principle of equal pay for equal work prohibits workers of one sex engaged in work of higher value than the work of workers of the opposite sex from being paid less than the workers of the opposite sex. Upon remand, the Irish High Court sent the case back to the Labour Court with the instruction that the Labour Court should make a ruling as though the applicant women and the male comparator were engaged in "like work." See Common Market Law Reports, No. 2, 1988, p. 753.

Developed Countries↗

Re Protection of Women: E.C. Commission v. France, 25 October 1988.

The European Court of Justice held that French legislation allowing the continuation in collective agreements and employment contracts or trade usages of certain privileges for women and leaving it to collective bargaining to make changes was in breach of Sex Discrimination Directive 76/207. It ruled that the privileges, such as reduction in working hours for women aged 59, bringing forward the retirement age, time off for sick children, an extra day's holiday per year for each child, hours off on Mother's Day, and daily breaks for women working on computer equipment or as typists or switchboard operators, were much wider than the privileges relating to pregnancy and maternity authorized in Article 2(3) of the Directive. It also ruled that such privileges were not justified by the precise objective of Article 2(4) of eliminating de facto inequalities in working life and that changes in the agreements, contracts, and usages should not be left to collective bargaining.

Developed Countries↗

Re Sex Discrimination in the Civil Service: E.C. Commission v. France, 30 June 1988.

The European Court of Justice held that French laws that allow the separate recruitment of men and women for positions as police and prison officers were in conflict with Article 2(2) of Sex Discrimination Directive 76/207 on the implementation of the principle of equal treatment for men and women, in particular as regards access to employment. Article 2(2) authorizes exceptions to this general principle for those occupational activities for which, by reason of their nature or the context in which they are carried out, the sex of the worker constitutes a determining factor. The Court ruled that the positions at issue were not sufficiently transparent or sufficiently related to specific activities to justify inclusion within Article 2(2). It also ruled, however, that the position of head prison warden fell within Article 2(2).

Developed Countries↗

Sex Discrimination (Amendment) Order 1988 (S.I. No. 249), 17 February 1988.

This Order stipulates that certain provisions of the Sex Discrimination Act 1975 will not apply to acts involving discrimination in the employment field. Under these provisions, a certificate may be signed by or on behalf of the Secretary of State of the UK to the effect that an act was done for the purpose of safeguarding national security and is to be conclusive evidence thereof. The Order was made for the purpose of complying with European Community Council Directive 76/207, as interpreted by the European Court of Justice in Johnston vs. Chief Constable of the Royal Ulster Constabulary (see Annual Review of Population Law, Vol. 13, 1986, Section 630).

Developed Countries↗

Ventilatory functions in Croatian population in comparison with European reference values.

AIM: To compare ventilatory capacity of Croatian population with the ventilatory function values predicted by conventional equations based on measurements among European populations. METHODS: Ventilatory capacity and respiratory symptoms were determined in a group of 2,482 healthy non-smokers (1,162 men and 1,320 women). The measurements were performed with a pneumotach spirometer. Maximum expiratory flow volume curves (MEFV) were registered, and forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and flow rates at 50% (MEF50) and the last 25% of the vital capacity (MEF25) were recorded. Anthropometric data were also noted. Reference values were calculated using multiple linear regressions. RESULTS: Comparisons of our values with the prediction summary equations issued by the European Community for Steel and Coal (ECSC) and the European Respiratory Society (ERS) showed that healthy Croatians had consistently lower values of FVC (92.1-/+14.0% of the predicted volume for men and 86.2-/+11.7% for women) and FEV1 (93.7-/+14.8% of the predicted values for men and 95.3-/+13.1% for women), but higher values of MEF50 (107.8-/+30.1% of the predicted values for men and 103.4-/+22.8% for women) and MEF25 (117.3-/+41.0% of the predicted values for men and 117.9-/+34.0% for women) than the ECSC/ERS recommendations. The comparison was also made with the most commonly used North American reference standards based on populations of European origin, with similar findings. On the basis of the results of multiple linear regressions, we constructed prediction equations for ventilatory function in Croatian population. CONCLUSION: The ECSC/ERS recommendations are not satisfactory for the Croatian population.

Adult↗

EC-collaborative study on the determination of aflatoxin B1 in animal feeding stuffs.

A collaborative study was conducted to test a method, proposed in the European Community (EC) as a candidate-official method for the determination of aflatoxin B1 in compounded feeding stuffs. The study was undertaken on behalf of the European Commission's Community Bureau of Reference (BCR). It involved 25 laboratories from 11 EC countries. The method, based on chloroform extraction and Sep-Pak Florisil and C18 cartridge clean-up, offered either reverse-phase high performance liquid chromatography (HPLC) with iodine post-column derivatization, or two-dimensional thin-layer chromatography (TLC) as determinative steps. In the study, 22 laboratories applied HPLC, three laboratories applied TLC. The study involved six unknown samples. These consisted of blind duplicate samples of compounded feeding stuff, with target concentrations of aflatoxin B1 at less than 2, 8 and and 14 micrograms/kg. Statistical analysis of the HPLC data was carried out according to ISO 5725. For the less than 2 micrograms/kg sample, all reported aflatoxin concentrations were less than 2 micrograms/kg. At the 8 and 14 micrograms/kg level (pooled), repeatability (r) and reproducibility (R), expressed as ratios, were 1.4 and 1.7 respectively, and within-laboratory and between-laboratory coefficients of variation were 11% and 18% respectively. The study revealed that admittance of daylight in the laboratory caused losses of aflatoxin B1 and must be avoided. New glassware coming into contact with aqueous solutions containing aflatoxin B1 was found to be a potential cause of loss of aflatoxin B1. The method has been recommended to the European Commission to be considered for adoption in EC regulations.

Aflatoxin B1↗

Liver and pancreas transplantation in Europe--and in Hungary.

Liver transplantation (LT) is the sole treatment modality of most of diffuse liver diseases. Simultaneous-pancreas-kidney (SPK) transplantation is also a life saving operation for IDDM patients. Both procedures are established treatment options in the European Community (EC) and in the US. These procedures are performed in a significantly smaller number in Hungary. Having a larger demand for LT than the supply of cadaver donors alternative solutions are sought to increase the number of transplantable livers. In Hungary partly the shortage of donors and the shortage of recipients are the factors rendering the number of LTs and SPKs low. These factors can be changed by better organisation and good survival data that make the two procedures accepted by the community of physicians.

European Union↗